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Welcome to the Cancer Center's clinical trials online search tool. Clinical trials are studies designed to test the effectiveness of new treatments, including new drugs or new combinations of drugs. For additional information about these trials, call the Cancer Center's Clinical Research Management Office at (212) 851-4880.

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35 Results

Brain and Nervous System

ID:AAAA8631

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

The purpose of this study is to find out if the overall dose of radiation to the brain and spine can be reduced in children with medulloblastoma (brain cancer); Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAL0912

Institutional
Principal Investigator: Dr. Fabio Iwamoto

Adult: Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma

This Phase II part of this clinical research study is being conducted to learn if bevacizumab, when given with or without vorinostat, can help to control malignant gliomas, a type of brain tumor. The safety of these drug combinations will also be studied. Participants will be randomized into one of two groups, one that receives vorinostat with bevacizumab, and one that received bevacizumab alone. Vorinostat is designed to slow the growth of cancer cells or cause the cancer cells to die. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Bevacizumab has been FDA approved for some types of brain cancer, and vorinostat is FDA approved and commercially available for some types of lymphoma. The combination of the two drugs to treat glioblastomas is investigational. Initial participants will be assigned to a group by chance. After the first 20 participants are enrolled, participants will be more likely to be put into the group that is producing better results. Participants will take the study drug(s) for up to one year, or longer if their doctor decides it is in their best interest to continue. They will be removed from the study if their disease progresses or if they experience intolerable side effects. About 90 people will take part in this phase II study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM5052

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma

This is a phase 2 clinical research study of BGJ398 in patients with recurrent resectable or unresectable glioblastoma with a specific genetic alteration (FGFR amplification or translocation).Group 1 will enroll patients who are not eligible for surgical resection of their tumor. Group 2 will enroll patients who will have surgery as part of their routine care. The study drug BGJ398 binds and blocks a family of proteins called fibroblast growth factor receptor (FGFR). FGFRs are part of pathway (a series of chemical reactions between proteins) that helps cells to function normally. In some types of cancers, this pathway becomes too active, which can cause tumor cell growth. BGJ398 has been shown to stop cancers in laboratory and animal studies and is being tested in human clinical studies.A treatment cycle consists of 28 days. During each 28-day cycle subjects will take BGJ398 once a day on days 1 through 21. If subjects undergo surgery, subjects will receive BGJ398 once daily for 5-10 days before surgery. After the surgery, and based on the Study Doctor’s judgment, patients will resume treatment and receive BGJ398 once daily in a 28 days cycle (three weeks on and one week off). Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAC7030

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

The overall goal of this study is to compare the effects, good and/or bad, of the chemotherapy drugs carboplatin and isotretinoin on subjects with high risk medulloblastoma and to find out if one or both are better than standard therapy alone. In this study the patient will get either standard therapy alone, standard therapy plus one of the chemotherapy drugs added to the regimen, or standard therapy plus both of the chemotherapy drugs. Both radiation therapy and the drug carboplatin have an anticancer effect when given alone. However, studies have shown that when carboplatin is given along with radiation therapy a greater effect is produced than when either is given alone. In this study we will look at whether giving radiation therapy and carboplatin together can improve the rate of survival of subjects with high risk medulloblastoma. This study will look at whether adding isotretinoin to the standard chemotherapy drugs can improve the rate of survival of children with high risk medulloblastoma. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAD0806

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS0334: A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children lt; 36 months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Resc

The purpose of this study is to compare two experimental treatment regimens to see if one is better for subjects with high risk medulloblastoma or primitive neuroectodermal tumor (PNET). Each regimen consists of induction, consolidation, and blood stem cell rescue. The difference in the regimens is that in one regimen an additional drug, methotrexate, will be added to the induction therapy. We would like to know if adding methotrexate will prove more effective than not adding methotrexate during induction therapy. We will also collect some blood for these research tests. About 1 teaspoon of blood will be taken before the subject starts treatment. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAF1551

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

This is a phase III trial of post-radiation chemotherapy in patients with newly diagnosed ependymoma. Subjects will be randomized to receive one of two different treatment plans. The treatment plans involve radiation therapy and may also include chemotherapy.The 2 different treatment plans are the same except for what happens after radiation therapy.The 2 treatment arms are called Arm A and Arm B, as follows:? Arm A: Radiation therapy followed by observation (no further treatment). This is thestandard therapy for patients with newly diagnosed ependymoma.? Arm B: Radiation therapy followed by Maintenance chemotherapy. Treatment withMaintenance chemotherapy is experimental.Subjects will be randomized to receive treatment on Arm A (radiation therapy and no furthertreatment) or to receive treatment on Arm B (radiation therapy and Maintenance chemotherapy).The radiation therapy will be the same in both groups of subjects. The researchers will request permission to use remaining tumor samples, taken for diagnostic purposes, for optional biology studies.It is anticipated that 400 subjects will participate in the overall study and 35 at the Columbia University Medical Center. The length of treatment on this study depends on the treatments patients receive. Radiation therapy lasts about 6 weeks. Chemotherapy lasts about 12 weeks. The length of treatment will range from about 6 weeks for subjects on Study Arm A to about 18 weeks for subjects on Study Arm B. After treatment, subjects will have follow-up examinations and medical tests. Medical information will continue to be collected for 10 years after participants enter the study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAK3201

Cooperative Group
Principal Investigator: Dr. Andrew Lassman

Adult: PHASE III TRIAL ON CONCURRENT AND ADJUVANT TEMOZOLOMIDE CHEMOTHERAPY IN NON-1P/19Q DELETED ANAPLASTIC GLIOMA: THE CATNON INTERGROUP TRIAL

This is a randomized Phase III clinical trial for patients who have been newly diagnosed with an anaplastic glioma, a type of brain tumor. The purpose of this study is to determine whether the addition of temozolomide treatment to radiotherapy, or the addition of temozolomide treatment after completion of radiotherapy (adjuvant treatment), will improve the results of the treatment. This study will find out what effects, good and/or bad, the addition of temozolomide has when it is given at the same time as radiotherapy, after radiotherapy, or both.There will be 748 subjects enrolled at all sites, with ten being enrolled at Columbia University Medical Center. The subject will be randomized into one of four groups. The subject will either receive radiotherapy alone for 6-7 weeks; the subject will take temozolomide once daily for the duration of radiotherapy treatment; the subject will take temozolomide once daily for 5 days every 28 days (up to 12 cycles) 4 weeks after radiotherapy has been completed; or the subject will receive radiotherapy and take temozolomide once daily for the duration of the radiotherapy, as well as once daily for 5 days every 28 days four weeks after the completion of radiotherapy. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAK8750

Institutional
Principal Investigator: Dr. Andrew Lassman

Adult: Phase I/II Study of AMG 386 with and without Bevacizumab for Recurrent Glioblastoma

This is a Phase I/II clinical trial to test the effectiveness of the investigational drug AMG 386 as a treatment for recurrent glioblastoma. Investigational means that the drug is still being studied and that researchers are still finding out about what doses are safest, what side effects are observed, and if it is effective in treating recurrent glioblastoma. The first participants accrued to this trial will be treated with AMG 386 exclusively. This study drug is administered by an hour-long infusion once every 4 weeks. The participants receiving this treatment are part of cohort A. After cohort A reaches 14 participants the investigators will evaluate the initial efficacy of AMG 386. If this study drug shows more efficacy than the standard of care, which is treatment with bevacizumab only, more participants will be accrued to cohort A. After completion of cohort A, a second group, which is called cohort B, will receive AMG 386 in combination with bevacizumab. Phase I of cohort B will determine the maximum tolerated dose of this combination. In Phase II, the investigators will determine the efficacy of AMG 386 and bevacizumab compared to AMG 386 by itself. The efficacy is measured by 6-month progression free survival. All participants will have an MRI once every 8 weeks. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM3463

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A Phase Ib/II, open-label, multicenter study of INC280 in combination with buparlisib in adult patients with recurrent glioblastoma

INC280 is a very potent and specific blocker of the c-MET protein. c-MET is a protein that acts as the ‘trigger’ to start a series of events in cells in what is known as the c-MET pathway. In normal cells, the triggering of this pathway allows for cell growth and survival.BKM120 (buparlisib) belongs to a group of medicines called PI3K (phosphatidylinositol 3’- kinase) -inhibitors which suppress a protein called PI3K which is controlled by a PIK3CA gene. PI3K has influence on the cell-to-cell communication and can therefore affect growth, survival and regulation of cancer cells. BMK120 interferes with this communication and therefore slows the tumor growth.As of September 2012, approximately 66 patients with cancer have been treated with INC280, and at least 212 patients with cancer have been treated with BKM120 (buparlisib). However, this is the first time these two medicines will be investigated in combination in patients.Subjects will be asked to take capsules of INC280 twice a day and capsules of BKM120 (buparlisib) once a day, for as long as they benefit from the treatment or at least their disease does not worsen and they have no unacceptable side-effects. In addition, a small group of patients may undergo surgery of their brain tumor, if they are found eligible by the Study Doctor.This study will also help understand what the drug combinations do to the body, and assess what the body does to clear the drugs from its system. For this reason, a number of pharmacokinetic (PK) blood samples will be collected during the study. Tumor and blood samples will also be collected to help identify genetic markers (differences in your DNA) or other biomarkers found in the tumor compared to the normal, non-tumorous cells that may explain any differences in the response to the study treatments.About 60-70 patients will join in this study in Spain, Switzerland, The Netherlands, Germany and USA. There might be more centers/countries participating if needed. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAI1118

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS0821: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblatoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

This is a study comparing treatment plans that include the drugs Temozolomide and Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for the treatment of Childhood Recurrent/Refractory Medulloblastoma/CNS PNET The overall goals of this study are to: o Determine what effects giving temozolomide together with irinotecan daily for 5 days every 28 days has on people with recurrent or refractory medulloblastoma/PNET. o Determine the effects of adding bevacizumab to treatment with temozolomide and irinotecan Treatment will be given in cycles that last 4 weeks (or 28 days) each. Participants will get 2 cycles of treatment and then there will be an evaluation. Imagining studies (scans) will be performed to see if the tumor has changed. If the tumor has not gotten larger and participants do not have bad side effects, they will continue with 2 more cycles of treatment. Then they will have another evaluation of their tumor. After the fourth cycle, the study doctor may suggest that participants continue with treatment if their tumor is shrinking or staying the same size and they do not have bad side effects. If this happens, up to 8 more cycles of treatment may be given, for a total of 12 possible cycles.The two different treatment plans are the same except for the drug bevacizumab. The two treatment arms are called Arm A and Arm B as follows:? Arm A: (TEMO+IRIN) - Treatment with temozolomide and irinotecan? Arm B: (TEMO+IRIN+BEVA) - Treatment with temozolomide and irinotecan and bevacizumab After treatment, subjects will have follow-up examinations and medical tests, including MRI scans. Medical information will continue to be collected on participants for 5 years after enrollment.The total number of people enrolled on this study is expected to be 108 and 15 at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAI1661

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ANBL0032: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch 14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

This is a Phase III randomized study of chimeric antibody 14.18 (Ch 14.18) in high risk neuroblastoma patients following myeloablative therapy and autologous stem cell rescue. This study will enroll participants who received and responded to chemotherapy, surgery, radiation therapy, and stem cell transplant treatment. The purpose of this study is to evaluate an experimental treatment aimed at maintaining or improving the patient?s response to previous treatments.Once participants are registered on this study, they will receive the experimental treatment ch14.18 + Interleukin-2 + GM-CSF + Isotretinoin (Accutane). All patients entered onto the study will get the same treatment. Ch14.18 represents a new kind of cancer therapy that, unlike chemotherapy and radiation, targets the destruction of cancer cells without destroying nearby healthy cells. GM-CSF and Aldesleukin (IL-2) will be used to determine whether they can help improve the efficacy of ch14.18 in patients. Isotretinoin is a drug closely related to vitamin A which has been shown to help stop the multiplication of remaining neuroblastoma cells.Standard Medical tests will be performed such as physical exams, blood tests, bone marrow tests, scans, tests of kidney, lung and heart function, and urine tests. The treatment portion of the study will last about 6 months. Information will be collected about participant?s medical conditions for ten years after they enter the study. It is anticipated that a maximum of 893 patients will be treated overall on this study, and 20 will be treated at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAJ6159

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Phase III CLINICAL TRIAL EVALUATING DCVaxreg;-L, AUTOLOGOUS DENDRITIC CELLS PULSED WITH TUMOR LYSATE ANTIGEN FOR THE TREATMENT OF GLIOBLASTOMA MULTIFORME

This is a Phase III research study of the investigational study agent, DCVax–L for subjects who have a form of brain cancer that may not be optimally treated by surgery + radiation + chemotherapy alone.The purpose of this clinical trial is to determine whether DCVax-L can slow the growth and recurrence ofa patient's brain tumor and whether DCVax-L can extend overall survival. Other goals of this trial are totest the safety and activity of DCVax-L and to determine whether the investigational study agent causes an immune response against cancer cells as compared to standard treatment or another experimental treatment.Eligible subjects will undergo a leukapheresis, which is a procedure to harvest their white blood cells.These cells are necessary to prepare a component of the DCVax-L treatment.Subjects will receive standard treatment for their disease, which includes surgery + radiation +chemotherapy in addition to either the investigational study agent called DCVax-L or a placebo. If it is determined that you have disease progression, you will be offered a crossover (open label) option to receive DCVax-L after progression has been verified.All subjects who have undergone the leukapheresis will receive up to 10 injections of the investigational study agent or placebo over the course of 3 years, except for those subjects for whom it is determined that it is not safe for them to receive either treatment. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAK7100

Institutional
Principal Investigator: Dr. Fabio Iwamoto

Adult: Phase II Study of Bevacizumab and Temozolomide in Elderly Patients With Newly Diagnosed Glioblastoma.

Elderly patients can experience many side effects with radiation therapy, such as memory loss. The purpose of this study is to evaluate the activity of the experimental drug Bevacizumab when given with Temozolomide among elderly patients (70 years of age or older) with a newly diagnosed brain tumor. Temozolomide is an FDA approved chemotherapy agent. The investigators will monitor the safety of this drug combination, the frequency and severity of side effects, and whether or not Bevacizumab with Temozolomide is effective in shrinking tumors without radiation therapy.This study is sponsored by The University of California, Los Angeles. A total of 50 patients will be enrolled into this study, with approximately 10 subjects at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAI9507

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACCL0922: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAL1401

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects with Glioblastoma Multiforme

This is a Phase I research study of an investigational drug called ABT-414 in participants with glioblastoma multiforme (GBM). The drug is investigational because it has not yet been tested in humans. The usual treatment for GBM is radiation therapy in combination with temozolomide, a chemotherapy drug that has been approved by the FDA for the treatment of GBM. Investigators hope that ABT-414 might make the temozolomide kill cancer cells more efficiently when the two are given in combination either with or without radiation, as well. The purpose of this Phase I study is to evaluate the safety of ABT-414 in combination with radiation and temozolomide, as well as how participants tolerate the drug and any side effects they may experience. Participants will be part of one of two groups, also known as Arms, depending on their current treatment plan for GBM. Those in Arm A will receive ABT-414 in combination with radiation and temozolomide. Those in Arm B will receive ABT-414 in combination with temozolomide without radiation. Approximately 48 people with GBM will participate in this study at five sites around the world. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAJ8500

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ACNS1022:A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

This is a Phase II Randomized Trial of Lenalidomide in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas. This study will examine how well lenalidomide works to keep the JPA or OPG from getting worse when given to children, adolescents and young adults with recurrent/refractory/progressive tumors. The use of lenalidomide in children is experimental.Lenalidomide is a drug that is approved by the Food and Drug Administration (FDA) to treat adults who have anemia caused by a condition called myelodysplastic syndrome (MDS) and to treat adults who have a type of cancer called multiple myeloma. It is also being studied in adults with other types of cancers. Lenalidomide has been used in a study of children with relapsed/refractory cancers and in another study of children with recurrent, refractory, or progressive brain tumors. Results from this second study show that lenalidomide is well-tolerated and appears to have some effect on childhood brain tumors. The overall goal of this study is:? To find out what effects, good and/or bad, a low dose and a high dose of lenalidomide have on children, adolescents and young adults with recurrent/refractory/progressive JPA or OPG. In this study, subjects will be selected to get 1 of 2 treatment plans. The treatment plans are the same except for the dose of lenalidomide that is given. Treatment will be given in cycles that last 4 weeks (or 28 days) each. During each cycle, participants will take lenalidomide for 21 days and then have a 7-day rest. They may receive up to 26 cycles of treatment, depending on how the tumor responds and if they develop side effects from the treatment. The following tests will be done as part of this study. - Pregnancy testing- Copies of the scans used to diagnose the cancer and scans taken to see how the subject?s tumors are responding to treatment will be sent to a central review center as part of COG quality control.- Blood tests will be taken for a pharmacokinetic (or PK) study. These tests are important to help researchers learn more about what happens in the body after lenalidomide is taken. The total number of people enrolled on this study is expected to be 80 and 18 at Columbia University Medical Center. People in this clinical trial are expected to receive treatment on this study for about 24 months (2 years). After treatment, they will have follow-up examinations and medical tests. Staff would like to continue to find out about participant?s health every year for about 5 years after they enter this study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAJ9953

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The ?ACT IV? Study)

This is a Phase 3 study. A phase 3 study is a study that is designed to confirm the results seen in earlier studies with the investigational agent. About half of the patients will receive rindopepimut and half will receive KLH. The study treatments will be blinded, which means that neither you nor your study doctor will know whether you are receiving rindopepimut or KLH. This kind of study is called a ?randomized, double-blind, controlled study,? and it is the best way to determine the effect of rindopepimut on newly diagnosed glioblastoma. Rindopepimut is an investigational medication. An investigational medication is one that is not approved by the U.S. Food and Drug Administration (FDA) for U.S. for use by the general public. Because this is a research study, rindopepimut will be given to you only during this study and not after the study is over.The purpose of this research study is to find out whether adding treatment with rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and helps subjects with brain tumors live longer than treatment with temozolomide alone. Temozolomide is a standard treatment for glioblastoma and all patients in this study will be administered temozolomide according to routine practice. The study will also see how treatment affects your quality of life. Additional studies may be performed to see how the subjects immune system is reacting to the treatment. The study will also see what side effects there are when injections of rindopepimut are given along with the commonly used temozolomide chemotherapy. Subjects assigned to receive temozolomide alone will be given a different compound, Keyhole Limpet Hemocyanin (KLH) as a ?control? injection. A control injection is a shot that is given without any expected therapeutic benefit. The purpose of the control is to disguise which treatment you are receiving from you and your doctor. KLH is one of the components (or parts) of the rindopepimut vaccine as well. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAL6854

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients with Newly Diagnosed Glioblastoma

Glioblastomas are the most frequent type of brain tumor. The standard treatment of surgery with radiation/chemotherapy only moderately improves outcomes. This trial will evaluate whether adding an experimental drug called PLX3397 to radiation therapy and temozolomide (a chemotherapy drug) will improve their efficacy. PLX3397 is experimental because it has not yet been approved by the U.S. Food and Drug Administration (FDA).Participants will be patients with newly diagnosed glioblastoma who have recovered from initial surgical resection. This study has two phases. The first, 1b, will evaluate the safety of increasing the dose levels of PLX3397, and determine the maximum tolerated dose for Phase 2 participants. In the absence of progressive disease or intolerable side effects or toxicities, participants can take PLX3397 for up to 12 cycles. Each cycle is 28 days. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAL7001

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ANBL12P1: Pilot Study Using Myeloablative Busulfan/Melphalan(BuMel) Consolidation Following Induction Chemotherapy for patients with Newly Diagnosed High-Risk Neuroblastoma

This is a multicenter Pilot study to determine if the effects of an autologous stem cell transplant (ASCT) with a Busulfan/Melphalan (BuMel) based regimen are tolerable when given as consolidation therapy in children and young adults with newly diagnosed high risk neuroblastoma. In addition, Melphalan pharmacokinetics will be evaluated to see if it is associated with non- hematologic toxicities within 28 days.The treatment plan on this study involves chemotherapy, ASCT, surgery and radiation therapy. Treatment is divided into 2 phase of therapy called Induction and Consolidation. The third phase standard treatment is not a part of this study. Information obtained will be collected and analyzed to determine if this treatment will be more beneficial to patients compared to historical regimens. The treatment will take about 8 months to completeStandard Medical tests will be performed such as physical exams, blood tests, bone marrow tests, imaging, hearing tests, kidney tests, lung and heart function test, and urine tests. It is anticipated that a maximum of 138 patients will be treated overall on this study with a maximum of 6 patients who will be treated at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAL6001

Institutional
Principal Investigator: Dr. Andrew Lassman

Adult: Phase II Trial of VELCADE (Bortezomib) in Combination with Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients with Newly-diagnosed Glioblastoma Multiforme.

Glioblastomas account for 40% of all primary malignant brain tumors and are the most aggressive form of brain cancer. The standard treatment for these tumors is surgery and radiation combined with chemotherapy. The prognosis following treatment is poor, however, and there is a clear need for more effective treatment regimes. This is a Phase II trial that will evaluate whether adding bortezomid to treatment with radiation and temozolomide (Food and Drug Administration [FDA] approved chemotherapy agent) is safe and more effective in treating patients with newly-diagnosed glioblastoma. This study is for patients who have not had prior treatment for their tumor (other than surgery). Bortezomid has been approved by the FDA for the treatment of myeloma and relapsed mantle cell lymphoma. Preliminary clinical evidence has shown activity of bortezomid against glioblastomas. Studies with other types of tumors have shown increased efficacy of temozolomide and radiation with the addition of bortezomid. This study will also determine whether the presence of genetic alterations or specific proteins in the tumor samples of participants can help predict if bortezomid will be effective. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAK3109

Externally Peer Reviewed
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: A Phase I Trial of Lenalidomide and Radiotherapy in Children with Diffuse Intrinsic Pontine Gliomas and High-grade Gliomas

This is a Phase I multicenter study evaluating the toxicity and efficacy of adding lenalidomide to standard involved field radiation therapy in the treatment of brainstem glioma and high grade glioma in pediatric patients. Lenalidomide has demonstrated activity in low grade glioma in a prior study and this study will test whether it adds to radiation. Lenalidomide is given by mouth daily during radiation for 21 days out of each 28 day cycle after radiation. The first patients treated will be given a low dose. If that dose proves safe, subsequent patients will be given a higher dose until the maximum safe dose is found. There will be about 18-30 patients participating in this study overall and about 6 will be treated at Columbia University Medical Center. The study treatment is considered experimental because the United States (US) Food and Drug Administration (FDA) has not yet approved it for treating children and young adults. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAJ6907

Institutional
Principal Investigator: Dr. Jeffrey Bruce

Adult: Fluorescence-guided resection of BRAIN TUMORS

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAN8010

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme

The goal of this research study is to find out if SL-701 is safe and tolerable. This study will also look at what effect SL-701 has on brain tumors.SL-701 is a type of anti-cancer vaccine made up of parts of 3 different short proteins called “peptides” which are frequently found on this type of brain tumor. The vaccine is intended to activate the immune system to recognize and kill the brain tumor cells that have the same protein. Not everyone’s immune system will respond to these peptides; the peptides are called “human-leukocyte antigen (HLA)-A2 restricted peptides” and 33% to 50% of people’s immune systems are expected to recognize these; this is determined by a blood test. If a patient's blood test indicates that their immune system is the HLA-A2 type, then they may be eligible to participate in the study.Subjects will come to the study center every 2 weeks over the course of approximately 22 weeks to receive study treatment, and then treatment will occur every 4 weeks thereafter. The total number of visits subjects will have in this study will depend on how they tolerate the study treatment (whether or not there are side effects) and, if their tumor gets worse.Subjects will be asked to return to the clinic 2 weeks after they receive their last dose of study treatment. The study staff will then contact subjects by phone approximately 1 month after their last dose of study treatment and then every 3 months to see how they are feeling.At each study visit where subjects receive study treatment, their study visit may last about two (2) hours. This is an additional one and half (1½) hours for each visit than if subjects were receiving chemotherapy only.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAO2801

Cooperative Group
Principal Investigator: Dr. Alice Lee

Both: ACNS1123: Phase 2 trials of response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS-GCT)

This is a research study for subjects who have diagnosed with a type of brain tumor called a germ cell tumor. A germ cell tumor can be malignant and can sometimes spread through the brain and spinal canal before symptoms appear. Normal germ cells are the body’s reproductive cells which are usually found in reproductive organs. Germ cells typically give rise to egg cells in ovaries of females and sperm cells in the testicles of males.The current standard treatment for newly diagnosed localized germinoma germ cell tumors in the brain is radiation therapy. Until recently, the radiation was usually given to the brain and spinal cord. This type of radiation therapy is called craniospinal irradiation (or CSI). In addition, radiation has also been given as whole ventricular irradiation (or WVI). Due to the possible long term effects from radiation, this study is looking at giving WVI and reducing the radiation therapy delivered after chemotherapy in order to minimize long term effects.The current standard treatment for newly diagnosed non-germinomatous germ cell tumors (NGGCT) in the brain is chemotherapy followed by radiation therapy. This study will look at giving WVI in reduced doses for NGGCT after chemotherapy in order to decrease long term effects from radiation therapy.A total of 168 subjects will be enrolled nationwide. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAN9255

Institutional
Principal Investigator: Dr. Fabio Iwamoto

Adult: BTTC12-01: A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab

This study is for patients with glioblastoma (brain tumor) that is recurrent (has returned after treatment).In this study, subjects will be assigned to a study group based on if they have received bevacizumab or not:- You will be in Group A if you have not received bevacizumab in the past.- You will be in Group B if you have received bevacizumab in the past.Both groups will receive pazopanib and topotecan at the same dose level and on the same schedule. Subjects will take capsules of topotecan by mouth 1 time every day, and tablets of pazopanib by mouth 1 time every day. Up to 34 participants will be enrolled in Group 1 and up to 32 participants will be enrolled in Group 2.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM3003

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: A Phase 1 Study of MK-1775 (IND#116459) Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas

This is a phase I, multicenter, dose escalation study of MK-1775 in combination with radiation. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG). MK-1775 is an oral selective Wee1 kinase inhibitor that works by inhibiting cancer cell growth. In this study, MK-1775 will be administered in combination with standard radiation therapy regimen. The purpose of this study is to evaluate the toxicities and clinical activity of MK-1775 in children with newly diagnosed with DIPG. Radiation therapy will be given at the current standard dose once daily Monday through Friday for a total of 30 doses over 6 weeks. MK-1775 will also be given based on the assigned dose level once daily Monday through Friday after that day’s radiation therapy, for a total of 30 doses over 6 weeks. Disease assessment will be completed before beginning treatment, before starting a new cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study. During every cycle, blood samples will be collected to determine how much MK-1775 is in the blood (pharmacokinetics). The blood tests will help us to better learn how to use this drug for children who may receive it in the future. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM5054

Institutional
Principal Investigator: Dr. Andrew Lassman

Adult: A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy

This is a phase II study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. A phase II study is set up to look at the safety and effectiveness of a new drug or an existing drug in a new population or disease.Subjects will be asked to participate because they have a type of cancer called a solid tumor cancer, and their cancer has metastasized (spread) to their brain. Subjects will have already undergone a type of treatment for the cancer in their brain called “whole brain radiation therapy” and their doctor has determined that the cancer in their brain has continued to grow or spread while their solid tumor cancer remains stable. The drug that will be used in this study, bevacizumab, is being tested to see what effect it will have on brain disease from solid tumor cancers. This study will not evaluate the effect of bevacizumab on the solid tumor cancer.Bevacizumab is a medication that blocks the growth of new blood vessels. In order for tumors to grow, they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that bevacizumab may interfere with the growth of new blood vessels; therefore it might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Bones and Joints, Brain and Nervous System, Kidney, Liver

ID:AAAO2953

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1315, A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# 123101) in Children with Recurrent or Refractory Solid Tumors

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM3801

Institutional
Principal Investigator: Dr. Andrew Lassman

Adult: Pilot Trial of Temsirolimus and Perifosine in Recurrent/Progressive Malignant Gliomas

Thepurposeofthisstudyistotesttheeffectivenessofadrugcalledtemsirolimusincombinationwithadrugcalledperifosineintreatingbraintumorsthathavecontinuedtogrowafterprevioustreatment.TemsirolimusisanintravenousdrugapprovedbytheFDAfortreatmentofothercancers(kidneycancer,certaintypesoflymphoma)butnotforbraintumors.PerifosineisapillthathasnotbeenapprovedbytheFDAwhichblocksamessengerthattellscancercellstogrow.Researchsuggeststhatcombinedtreatmentwithbothdrugsisbetterthaneitheralone,andthatitisreasonablysafe.SubjectswillbeenrolledineitherGroupAorGroupB,dependingontheireligibilityforsurgery.Bothgroupswillbetreatedwiththecombinationofperifosineandtemsirolimus. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Bones and Joints, Brain and Nervous System, Kidney, Liver, Lymphoid Leukemia, Soft Tissue

ID:AAAN6705

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Both: A Phase 1/2 Study of BMN 673 (IND #121510), an Oral Poly(ADP-ribose) Polymerase Inhibitor, Plus Temozolomide in Children with Refractory or Recurrent Malignancies

This is a phase I, multicenter, dose escalation study of BMN 673 in combination with temozolomide. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with relapsed or recurrent malignancies. BMN 673 is a PARP inhibitor that works by inhibiting cancer cell growth. In this study, BMN 673 will be administered in combination with temozolomide. The purpose of this study is to evaluate the toxicities and clinical activity of BMN 673 in children with relapsed or recurrent malignancies.BMN 673 will be given at the current standard dose once daily on days 1 through 6 of a cycle. Temozolomide is given once daily on days 2 through 6 of a cycle. A cycle is 28 days. Disease assessment will be completed before beginning treatment, before starting a new cycle, at the end of treatment. During every cycle, blood samples will be collected to determine how much BMN 673 is in the blood (pharmacokinetics). The blood tests will help us to better learn how to use this drug for children who may receive it in the future. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Bones and Joints, Brain and Nervous System, Kidney, Liver, Soft Tissue

ID:AAAM3002

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1213: A Phase 1 study of the TEM-1 antibody, MORAb-004 (IND# 103821), in Children with Recurrent or Refractory Solid Tumors

This is a phase I, multicenter study of the TEM-1 antibody, MORAb-004. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with recurrent or refractory solid tumors. MORAb-004 is an antibody that works to inhibit tumor growth and metastasis . The purpose of this study is to evaluate the toxicities and clinical activity of MORAb-004 in children with recurrent (tumors that have come back after being treated before) or refractory (tumors that are not responding to treatment) solid tumors. MORAb-004 will be administered intravenously once every seven days for four weeks, for a total of four doses. A cycle may be repeated every 28 days, for a maximum of 13 cycles, if the patient has at least stable disease and is eligible according to the laboratory parameters defined in the eligibility section. Disease assessment will be completed before beginning treatment; at the end of Cycles 3 and 5, then continuing every 3 cycles until the end of treatment. During every cycle, blood samples will be collected to determine how much MORAb-004 is in the blood (pharmacokinetics). The blood tests will help us to better learn how to use this drug for children who may receive it in the future. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM6851

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A phase II, two-tier study evaluating the efficacy and safety of Selinexor (KPT-330) in patients with recurrent glioblastoma after failure of radiation therapy and temozolomide

The purpose of this research study is to see if Selinexor (KPT-330) has any effects against glioblastoma, a type of brain cancer. The study will be conducted at 3-5 sites in the United States and Europe and plan to enroll 30 patients with brain cancer.Patients will be screened prior to study participation. If their brain tumor is evaluated to require surgery they will be assigned to Group A, and they will receive 2 or 3 doses of the study drug Selinexor and then undergo surgery. After recovery from surgery patients will resume treatment with Selinexor. If patients do not require surgery they will be assigned to Group B.Patients will take Selinexor twice weekly on days 1 and 3 of each week (Monday and Wednesday or Tuesday and Thursday). One cycle is 28 days (4 weeks) and includes 8 doses of Selinexor. The term “Cycle 1” is the first 4 weeks from the time patients take their first dose of Selinexor and “Cycle 2” is the following 28 days or 4 weeks. The length of time that patients receive study treatment will depend on how well they tolerate the study drug and the effect it has on their brain cancer. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Bones and Joints, Brain and Nervous System, Kidney, Liver, Soft Tissue

ID:AAAN4703

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1312, A Phase 1/2 Study of MK-1775 (AZD1775, IND# 121422) in Combination with Oral Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors

This is a phase I, multicenter, dose escalation study of MK-1775 in combination with irinotecan. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with refractory or recurrent solid tumors. MK-1775 is an oral selective Wee1 kinase inhibitor that works by inhibiting cancer cell growth. In this study, MK-1775 will be administered in combination with irinotecan. The purpose of this study is to evaluate the toxicities and clinical activity of MK-1775 in children with nrefractory or recurrent solid tumors. Both drugs will be administered orally on days 1-5 of a 21-day cycle . Disease assessment will be completed before beginning treatment, before starting a new cycle, and at the end of study treatment. During every cycle, blood samples will be collected to determine how much MK-1775 is in the blood (pharmacokinetics). Once the recommended phase 2 dose of MK-1775 in combination with irinotecan is determined, there will be a phase 2 expansion for patients with refractory or recurrent neuroblastoma (Part B) and for patients with refractory or recurrent medulloblastoma/CNS PNET (Part C). Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Bones and Joints, Brain and Nervous System, Kidney, Liver, Soft Tissue

ID:AAAM3603

Industry
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: A Phase 1/2, multicenter, open-label, dose-finding study to assess the safety, tolerability, and preliminary efficacy of weekly nabreg;-paclitaxel in pediatric patients with recurrent or refractory solid tumors.

This is a phase I, multicenter, dose finding study of nab-paclitaxel. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with recurrent or refractory solid tumors. Nab-paclitaxel is an human serum albumin bound nanoparticle formulation of paclitaxel that works by inhibiting cancer cell growth. The purpose of this study is to evaluate the toxicities and clinical activity of nab-paclitaxel in children with recurrent or refractory solid tumors. Nab-paclitaxel will be given based on the assigned dose level intravenously over approximately 30 minutes, on Days 1, 8, and 15 of a 28-day cycle. Disease assessment will be completed before beginning treatment, before starting a new cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study. During every cycle, blood samples will be collected to determine how much nab-paclitaxel is in the blood (pharmacokinetics). The blood tests will help us to better learn how to use this drug for children who may receive it in the future. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

Brain and Nervous System

ID:AAAM0762

Cooperative Group
Principal Investigator: Dr. Jeffrey Bruce

Adult: A PHASE II RANDOMIZED TRIAL COMPARING THE EFFICACY OF HEAT SHOCK PROTEIN-PEPTIDE COMPLEX-96 (HSPPC-96) (NSC #725085, ALLIANCE IND #15380) VACCINE GIVEN WITH BEVACIZUMAB VERSUS BEVACIZUMAB ALONE IN THE TREATMENT OF SURGICALLY RESECTABLE RECURRENT GLIOBLASTOMA MULTIFORME (GBM)

The purpose of this study is to compare the effects on brain tumors of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone. HSPPC-96 is experimental and is made from tissue taken from a subject’s brain tumor, which is then given back to the subject in the form of a vaccine that may work to help their body have a response against remaining brain tumor cells. Bevacizumab is approved by the FDA to treat brain tumors that grow back, and works by blocking a protein called VEGF (Vascular Endothelial Growth Factor) which is overproduced by cancer cells. The use of HSPPC-96 incombination with bevacizumab is investigational. After their surgery, subjects will be randomized into one of three study Groups. Subjects in Group #1 will receive HSPPC-96 with bevacizumab. Subjects in Group #2 will receive HSPPC-96 and will be given bevacizumab if their tumor comes back. Subjects in Group #3 will receive bevacizumab alone. Subjects will participate in blood tests, urine tests, physical and neurological examinations, as well as brainMRI or CT scans. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-851-4880.

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