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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.

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43 Results

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 about this trial, please call 646-317-0540

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 < 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 about this trial, please call 646-317-0540

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 about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAJ6159

Industry
Principal Investigator: Dr. Fabio Iwamoto

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

This is a Phase III research study of the 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 of a patient's brain tumor and whether DCVax-L can extend overall survival. Other goals of this trial are to test the safety and activity of DCVax-L and to determine whether the study agent causes an immune response against cancer cells as compared to standard treatment or another experimental treatment. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

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 about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAJ7500

Institutional
Principal Investigator: Dr. Andrew Lassman

Adult: Pilot Study of EGFR Inhibition using High Dose Administration of Erlotinib Weekly for Recurrent Malignant Gliomas with EGFR variant III Mutation

This is a pilot study of erlotinib for subjects who have a brain tumor called a glioblastoma or another malignant glioma, which has continued to grow after treatment.The purpose of this study is to test the effectiveness of a drug called erlotinib in treating the tumor. The study drug, erlotinib (also called Tarceva) is a pill (taken by mouth) that has been approved by the U.S. Food and Drug Administration (FDA) for the subjects with other cancers (lung cancer or pancreatic cancer). It is not approved for glioblastoma or another malignant glioma.Erlotinib blocks a messenger that tells cancer cells to grow. That messenger is called ?epidermal growth factor receptor? which is abbreviated ?EGFR? This type of tumor contains a form of EGFR called variant number 3 (abbreviated EGFR variant III or EGFRvIII for short) that is different from the normal form. Research suggests that erlotinib is particularly effective at stopping EGFRvIII. Research also suggests that high doses of erlotinib taken once per week may be more effective than low doses of erlotinib taken once per day. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

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 about this trial, please call 646-317-0540

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 is evaluating whether adding an experimental drug called PLX3397 to radiation therapy and temozolomide (a chemotherapy drug)will improve the efficacy of the standard treatment. 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 about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

Brain and Nervous System

ID:AAAJ6907

Institutional
Principal Investigator: Dr. Jeffrey Bruce

Adult: Fluorescence-guided resection of NEUROSURGICAL TUMORS

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

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 about this trial, please call 646-317-0540

Brain and Nervous System, Leukemia, other, Melanoma, skin, Myeloid and Monocytic Leukemia, Other Digestive Organ, Soft Tissue

ID:AAAO7704

Industry
Principal Investigator: Dr. Richard Carvajal

Adult: A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations

The primary purpose of this research study is to assess how safe and well tolerated the study drug, IDH305, is when given to patients who have advanced tumors that harbor IDH1R132 mutations. Pre-clinical data suggest the importance of these mutations in maintaining cancer. The hypothesis of this research study is inhibiting the mutant IDH1 mutation in these tumors will result in anti-tumor activity. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Richard Carvajal at 212-305-2055

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 about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAO8703

Cooperative Group
Principal Investigator: Dr. Tony Wang

Adult: NRG-BN001 Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide In Patients with Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation therapy schedule and higher radiation dose [higher dose group] to the standard dose of radiation therapy [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiotherapy dose could shrink patients' cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach. To be better, the study should increase life by six months or more compared to the usual approach. Two methods of giving radiation therapy will also be compared. They are proton beam radiation and intensity-modulated radiation. There will be about 576 people taking part in this study. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Tony Wang at 212-305-9097

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

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAP9655

Cooperative Group
Principal Investigator: Dr. Fabio Iwamoto

Adult: Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients with Newly Diagnosed Glioblastoma

Primary objectives:- To compare the overall survival (OS) of patients receiving IV rigosertib to the OS of patientsreceiving PC in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DEC)- To evaluate OS of patients with IPSS-R very high risk in the rigosertib vs PC group- To evaluate the safety and tolerability of rigosertib administered as 72-hour CIV infusions versus PC. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

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

ID:AAAN6705

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Both: ADVL1411: 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 about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAO1957

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: An Expanded Access Protocol for the Treatment of Glioblastoma Multiformed in Patients with Already Manufactured DCVax-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen Who Have Screen Failed Protocol 020221

The study is designed as an open-label expanded access study for patients for whom vaccine was manufactured during the 020221 (Protocol number AAAJ6159) screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (SOC) as well as active vaccine per the 020221 administration schedule. It is estimated that approximately 99 patients will enroll in this study.The purpose of this clinical trial is to determine whether DCVax-L can slow the growth of a patient's brain tumor and whether DCVax-L can extend overall survival. Other goals of this trial are to test the safety and activity of DCVax-L and to determine whether the 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. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

Brain and Nervous System

ID:AAAO4553

Institutional
Principal Investigator: Dr. Randolph Marshall

Adult: A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke.

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAO1252

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ANBL1232: Utilizing Response and Biology Risk Factors to guide Therapy in Patients with Non-Risks Neuroblastoma

This is a Phase III trial in patients with non high-risk neuroblastoma, or ganglioneuroblastoma. Patients will be assigned to different groups of treatment based on the patient’s age, tumor stage and biologic features. Patients will be assigned to one of three treatment Groups. Group A:Observation OnlyGroup B: Subjects in Group B will undergo an initial observation period of 8 weeks. After 8 weeks, a series of tests will be done to determine the tumor size and to look for any sign that the cancer has spread.If the tumor does not get bigger and the cancer does not spread then subjects will be observed on this study for up to 3 years.If the tumor gets bigger, treatment will be started with chemotherapy and/or surgery (if it can be safely performed). Subjects will be followed closely with scans and tests to see how well the tumor responds and the amount of treatment will depend on the tumor response. Treatment will continue until the tumor gets at least 50% smaller, at which time chemotherapy will be stopped and patients will then be closely observed. Group C:For very young subjects in Group C whose cancer involves the liver or subjects who have symptoms caused by the cancer treatment will be started to prevent any chance of complication. Subjects will be followed closely with scans and tests to see how well the tumor responds and the amount of treatment will depend on the tumor response. If subjects do not have symptoms and the tumor has good biology features, then subjects will be closely observed with frequent evaluations. If the tumor does grow, subject will start chemotherapy. Approximately 621 subjects are expected to go on study across all sites. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAO4805

Institutional
Principal Investigator: Dr. Teri Kreisl

Adult: Pilot Study of NovoTTF-100A for Recurrent Atypical and Anaplastic Meningioma

The purpose of this study is to find out what effects, good or bad, the NovoTTF-100A device has on patients and their meningioma. This study is being done because currently there are no proven effective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The study uses an experimental device called NovoTTF-100A. NovoTTF-100A is “experimental” because it has not been approved by the U.S. Food and Drug Administration (FDA) for your type of tumor, although it has been approved for a different type of tumor. The NovoTTF-100A System is a portable medical device. It delivers electric fields called“TTFields” to the brain using transducer arrays which are sticky pads placed on the scalp. TTFields are intended to kill cancer cells. Patients will be able to use the NovoTTF-100A System at home by themselves, or with help from a doctor, family member, or other caregiver. The NovoTTF-100A should be used as many hours per day as possible, but at least 18 hours. When starting treatment at the doctor s office, the study doctor will teach patients how to use the device. The NovoTTF-100A can be carried when patients are using a battery. Patients can continue normal daily life while carrying the device in a shoulder bag or backpack. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Teri Kreisl at 212-342-0571

Brain and Nervous System, Kidney

ID:AAAP1101

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Both: ADVL1412, A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab

This is a Phase 1/2 multicenter study of nivolumab as a single agent and in combination with ipilimumab. 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. The purpose of this study is to evaluate toxicity and potential antitumor activity of nivolumab, a PD1 blocking mAb, in children with refractory or recurrent solid tumors and to test a combination regimen of nivolumab plus ipilimumab, which has shown activity in melanoma.Nivolumab of 3 mg/kg (Dose Level 1) will be administered as a 60-minute intravenous infusion every 14 days of a 28 day cycle. If Dose Level 1 is not tolerable, then the 3 mg/kg dose will be deescalated to 1 mg/kg and a similar cohort of patients will be evaluated for tolerability at this dose.Once the recommended phase 2 dose of nivolumab is determined, there will be a phase 2 cohort expansion for patients with neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma, Hodgkin lymphoma and non-Hodgkin lymphoma. Concurrently there will be an expansion to test a combination regimen of nivolumab plus ipilimumab, with the goal of identifying the maximum tolerated dose or recommended phase 2 dose of this combination. Ipilimumab will be administered as a 90-minute intravenous infusion.The combination of nivolumab and ipilimumab will be administered every 3 weeks for four cycles followed by nivolumab given every 2 weeks. Cycle length is 21 days for the first 4 cycles and 28 days for subsequent cycles which comprise two doses of nivolumab. Disease assessment will be completed before beginning treatment, before starting a new cycle, and at the end of study treatment. Blood samples will be collected to determine how much nivolumab and ipilimumab are in the blood during the study (pharmacokinetics). Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAL5208

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC#683864, IND#61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma.

This is a Phase II randomized study of Irinotecan/Temozolomide with Temsirolimus or chimeric antibody 14.18 (Ch 14.18) in children with refractory, relapsed, or progressive neuroblastoma. This study will enroll participants who have the type of neuroblastoma that has come back after treatment (relapsed) or has not responded to treatment (refractory).Enrolled subjects will be treated with irinotecan and temozolomide combined with temisirolimus or irinotecan and temozolomide with chimeric 14.8 antibody (ch14.8). Temsirolimus and ch 14.18 are both experimental drugs that have not yet been approved by the Food and Drug Administration (FDA) for treating relapsed or refractory neuroblastoma.Standard Medical tests will be performed such as physical exams, blood tests, bone marrow tests, imaging, tests of kidney, lung and heart function, and urine tests. The treatment portion of the study may last for a maximum of 12 months. It is anticipated that a maximum of 74 patients will be treated overall on this study, and it is anticipated that 6 will be treated at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Anus, Bones and Joints, Brain and Nervous System, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Ill-Defined Sites, Kaposis sarcoma, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung, Lymphoid Leukemia, Melanoma, skin, Mesothelioma, Multiple Myeloma, Mycosis Fungoides, Myeloid and Monocytic Leukemia, Non-Hodgkins Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Hematopoietic, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Unknown Sites, Bladder

ID:AAAP0559

Industry
Principal Investigator: Dr. Richard Carvajal

Adult: Open-Label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Patients with Advanced Malignancies

The purpose of this research study is to find the highest safe dose of the drug MGCD265 that can be given to participants with advanced cancer. The safety of this drug, and the effect that it has on the particpants disease and your body will also be studied. MGCD265 is a drug that works by blocking proteins that are important for cancer cells to grow. MGCD265 also prevents the growth of new blood vessels that help cancer tumors grow and spread. MGCD265 an investigational agent. This means that MGCD265 is not approved by the Food and Drug Administration (FDA). Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Richard Carvajal at 646-317-6041

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 about this trial, please call 646-317-0540

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 nab®-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 about this trial, please call 646-317-0540

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 about this trial, please call Dr. Jeffrey Bruce at 212-305-7346

Brain and Nervous System

ID:AAAQ0962

Cooperative Group
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Randomized Phase 2 Trial for Myeloblative versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-Cell Lymphoma

This is a research study to test the effects of chemotherapy and stem cell transplant compared with chemotherapy alone on primary central nervous system (CNS) B-cell lymphoma. This study will enroll 160 subjects age 18-75 years who have primary CNS B-cell lymphoma. All subjects will be randomly assigned in a 1:1 ratio to receive either chemotherapy alone or chemotherapy and stem cell transplant, following an initial chemotherapy treatment received by all subjects. Imaging scans will be used to determine the effectiveness of each treatment. As the best treatment for patients with primary CNS B-cell lymphoma is not known, this study may help identify an effective treatment with limited negative side effects. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ6917

Industry
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous System Tumors That are Amenable to Direct Injection

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ2302

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

This is a Phase 2b/3 study to compare the effectiveness of the study drug ABT-414 against a placebo. Patients will be randomized to either receive the standard-of-care therapy which consists of ratiation therapy/TMZ plus adjuvant TMZ which will be followed by eiter the study drug ABT-414 or a placebo monotherapy. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ8904

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). This study will see if treatment with nivolumab increases the chance you will have a positive response (complete or partial) in treating your primary central nervous system lymphoma (PCNSL) or primary testicular lymphoma (PTL). It will also see if nivolumab improves your chances of survival and at delaying the worsening of your PCNSL or PTL (called progression). Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

Brain and Nervous System

ID:AAAQ1153

Industry
Principal Investigator: Dr. Teri Kreisl

Adult: A Phase 3, Randomized, Controlled, Double-Arm, Open- Label, Multi-center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with Recurrent Glioblastoma

This is a research study to test the effects of VB-111 combined with Bevacizumab versus Bevacizumab alone on glioblastoma . This study will enroll 252 subjects age 18 years and older who have recurrent glioblastoma. All subjects will be randomly assigned in a 1:1 ratio to receive either VB-111 combined with Bevacizumab or Bevacizumab alone. Survival, tumor response, and tumor growth rate will be used to determine the effectiveness of each treatment. As the best treatment for patients with recurrent glioblastoma is not known, this study may help identify an effective treatment with limited negative side effects. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Teri Kreisl at (212) 342-0571

Brain and Nervous System

ID:AAAQ8210

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Randomized Phase 2 Single Blind Study of Temozolomide plus Radiation Therapy combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma

The purpose of this study is to test the effectiveness (how well the drug works), safety, andtolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-2959

Brain and Nervous System

ID:AAAQ8187

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at 212-342-0571

Brain and Nervous System

ID:AAAQ7627

Cooperative Group
Principal Investigator: Dr. Teri Kreisl

Adult: Phase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are medications that target these 2 genes. The medication, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink your meningioma, or your meningioma could stay the same size or grow. The medication, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. GSK2256098 could shrink your meningioma, or your meningioma could stay the same size or grow. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAR0112

Industry
Principal Investigator: Dr. Andrew Lassman

Adult: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06840003 IN PATIENTS WITH MALIGNANT GLIOMAS

There are two parts to this study, dose escalation (Part 1) followed by dose expansion (Part 2). The dose of PF-06840003 for this study will begin at 125 mg taken 1 time a day. For Part 1 Tthe dose of PF-06840003 will be increased for each new dosing cohort (group of research subjects/participants) as long as the drug is safely tolerated (no unsafe or unacceptable effects on your body) and if drug concentrations of PF-06840003 in the blood have not reached sufficient levels. Once a dose has been determined in Part 1, Part 2 to will provide that dose to a larger group of research subjects/participants .
For more information about this trial, please call Dr. Andrew Lassman at (212) 342-0571

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

ID:AAAQ7819

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1621: A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ0959

Industry
Principal Investigator: Dr. Adam Sonabend Worthalter

Adult: A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

This is a research study to test the effectiveness of Toca 511/Toca FC, an experimental drug, for treatment of recurring brain tumors compared to current standard of care. The study will enroll 370 subjects age 18-85 years who choose to undergo removal of the tumor a second time. At the time of surgery patients will be randomly assigned in a 1:1 ratio to receive either the experimental drug or the standard of care. Treatment will begin approximately 6 weeks after surgery. Blood, tumor, and cerebrospinal fluid will be collected to determine the effectiveness of the new drug. Given the tendency of malignant brain tumors to recur and and the limited success of the current standard of care, Toca 511/Toca FG has the potential for improving the outcome of patients with recurring brain tumors. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

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

ID:AAAQ4204

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1414, A Phase 1 Study of Selinexor (KPT-330, IND #125052), a Selective XP01 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ6521

Industry
Principal Investigator: Dr. Alice Lee

Pediatrics: DIV-NB-401: A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin (Dinutuximab, monocolonal antibody ch14.18) in High-Risk Neuroblastoma Patients

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ1305

Industry
Principal Investigator: Dr. Fabio Iwamoto

Adult: A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy

This a research study to test the effectiveness of ICT-107, an experimental drug, with the standard of care (SOC) for treatment of glioblastoma compared to enriched blood cells (PBMC) with the SOC. The study will enroll 400 subjects age 18 years and older with newly diagnosed glioblastoma. Following an initial SOC radiation treatment, patients will be randomly assigned in a 1:1 ratio to receive either the ICT-107 with SOC or PBMC with SOC. Several survival rates will be used to determine the effectiveness of the new drug. Given the limited success of the current standard of care, ICT-107 has the potential for improving the outcome of patients with glioblastoma. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call Dr. Fabio Iwamoto at (212) 342-0571

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

ID:AAAQ5801

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1416, A Phase 1 study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children with Refractory Solid tumors, including CNS Tumors

Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:NYSPI 7290

Institutional
Principal Investigator: Dr. Margaret Haney

Adult: Investigation of cannabis for tolerability and feasibility in patients receiving concurrent chemoradiation for glioblastoma


For more information about this trial, please call 646-317-0540

Brain and Nervous System

ID:AAAQ8420

Cooperative Group
Principal Investigator: Dr. Tony Wang

Adult: A Randomized Phase III Trial Of Memantine And Whole-Brain Radiotherapy With Or Without Hippocampal Avoidance In Patients With Brain Metastases

The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus memantine will decrease the dose of radiation to your hippocampus. It is hoped hippocampal avoidance technique will decrease the chance of cognitive side effects, however it is possible hippocampal avoidance could have no impact on cognitive side effects and could even cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Memantine is already FDA-approved for use in patients with dementia and is commonly used off-label (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain radiation therapy for cancer that has spread to the brain. Please click here to view more information in ClinicalTrials.gov.
For more information about this trial, please call 646-317-0540

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