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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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9 Results

Kidney

ID:AAAF0256

Cooperative Group
Principal Investigator: Dr. Alice Lee

Pediatrics: AREN0534: Treatment for Patients with Bilateral Multicentric or Bilaterally Predisposed Unilateral Wilms Tumor

This is a Phase III clinical trial for patients with Bilateral, Multicentric or Bilaterally-Predisposed Unilateral Wilms Tumor. Children with bilateral Wilms tumor account for 5-7% of all patients with Wilms tumor. Certain patients,with syndromes associated with Wilms tumor development, have been identified to be at increased risk for bilateral tumors. Due to an increased risk for renal failure, patients with bilateral disease at presentation are treated with preoperative chemotherapy in order to preserve renal parenchyma. Although this recommendation was made nearly 30 years ago, patients with bilateral tumors have not been formally studied in prior cooperative trials. Recent evidence suggests that survival of these patients is inferior to similar patients with unilateral tumor. This study is designed to improve the survival of these children, while continuing the emphasis on preserving renal function.For subjects with Bilateral Wilms Tumor:Subjects will begin treatment with 6 weeks (2 cycles of three weeks each) of chemotherapy. The chemotherapy treatment plan is based on the type of cells in the tumors and the stage of the disease. Some kinds of tumor cells are more aggressive than other kinds;this means the tumor cells divide (grow) very fast. Stage is a way of describing how much the tumor has spread from the place where it started. A low stage tumor is one that has not spread,while a high stage tumor is one that has spread out into other places in the body.Subjects will get two different chemotherapy regimens for the first 2 cycles. All the drugs usedin these regimens are commonly used to treat Wilms tumor. In general, if subjects have a low stage disease with less aggressive cancer cells, they will get the three-drug regimen (VAD). If they have more aggressive tumors or higher stage disease, they will get a five-drug regimen (Revised UH-1).For subjects with Bilaterally-Predisposed Unilateral Wilms Tumor:Subjects will begin treatment with 6 weeks (2 cycles of three weeks each) of chemotherapy. Subjects will get one of three different chemotherapy regimens for the first 2 cycles. All the drugsused in these regimens are commonly used to treat Wilms tumor. If subjects have a low stage disease with less aggressive cancer cells, they will get the common two-drug regimen (EE-4A). If they have high stage disease with less aggressive cancer cells, or low stage disease with more aggressive cancer cells, they will get a three-drug regimen (VAD). For more aggressive tumors with high stage disease, they will receive a five-drug regimen (Revised UH-1).For subjects with Diffuse Hyperplastic Perilobar Nephrogenic Rests:Subjects will begin treatment with 6 weeks of chemotherapy (two cycles of 3 weeks each). The drugs that are commonly used to treat Wilms tumor are vincristine and dactinomycin.For all subjects, after the two cycles of chemotherapy they will be evaluated. The evaluation will include scans (CT or MRI) and often a biopsy to see if the tumor(s) has/have been changed by thechemotherapy. Then, the study doctor will determine what the next step will be. It can be:- more chemotherapy with the same set of drugs-more chemotherapy with a different set of drugs-surgery, then more chemotherapy with the same set of drugs-surgery, then more chemotherapy with a different set of drugs- surgery, then radiation therapy and more chemotherapy with the same set of drugs- surgery, then radiation therapy and more chemotherapy with a different set of drugsApproximately 150 subjects are expected to enroll in the overall study. The regimens last from 18 to 43 weeks. After treatment, subjects will have follow-up examinations and medical tests. Medical information about the subjects will continue to be collected for about 10 years after the last subject starts the study. Subjects will need to have a kidney ultrasound performed every 3 months for five years or until age 8 years. 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.

Kidney

ID:AAAI2800

Cooperative Group
Principal Investigator: Dr. Edward Gelmann

Adult: S0931, EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study

This is a phase 3 research study of everolimus for subjects who have cancer of the kidney that has been surgically removed.The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named ?mTOR?. Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, subjects will get either everolimus or placebo (a pill with no medication). Subjects will not get both. 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.

Kidney

ID:AAAM2650

Cooperative Group
Principal Investigator: Dr. Emerson Lim

Adult: RANDOMIZED PHASE II STUDY COMPARING CABOZANTINIB (NSC #761968 AND IND #116059) WITH COMMERCIALLY SUPPLIED SUNITINIB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

The purpose of this study is to find out what effects, good and/or bad, two study drugs called sunitinib and cabozantinib have on you and on advanced or metastatic kidney cancer. Sunitinib has been approved by the FDA and cabozantinib is an investigational drug. Both medications target special proteins that are on the surface of the kidney cancer cell and both drugs are taken by mouth.About 150 subjects will be enrolled for this study, of which 10 will be recruited from 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.

Bones and Joints, Kidney, Liver, Soft Tissue

ID:AAAN9957

Cooperative Group
Principal Investigator: Dr. Julia Glade Bender

Pediatrics: ADVL1314, A Phase 1 Study of Eribulin Mesylate (E7389, IND#116,292), a Novel Microtubule Targeting Chemotherapeutic Agent in Children with Refractory or Recurrent Solid Tumors, including Lymphomas.

This is a phase 1, multicenter, dose escalation study of Eribulin Mesylate, a novel microtubule targeting chemotherapeutic agent in children with refractory or recurrent solid tumors, including lymphomas. . 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. Participants are given eribulin as an intravenous infusion on Day 1 and Day 8. Eribulin mesylate will be given directly into the vein through either a needle or small tubing inserted each treatment day or through a long-term catheter called a central line. This treatment pattern will be repeated every 21 days. This entire 21-day period is called a cycle. During the study, 13 blood samples will be collected to see how much of the eribulin mesylate is in each participants blood. This may require that a small intravenous tube (catheter or IV) be placed since some of the samples cannot be drawn from the site of drug administration. The blood samples (3 mL or about teaspoon each sample) will be obtained before the drug is given, and 5 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours after the drug is given on Day 1 of Cycle 1. A final sample will be collected 5 minutes after the drug is given on Day 8 of Cycle 1. A total of 39 mL (about 8 teaspoons total) will be taken for the pharmacokinetic tests in this study. This amount of blood is safe to draw even from small children. 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.

Kidney

ID:AAAM8550

Industry
Principal Investigator: Dr. Mitchell Benson

Adult: An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

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.

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