Kidney
ID:AAAC3375
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
AREN0532, Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor
This study is for young patients with Wilms tumor. This protocol will study elimination of exposure to upfront chemotherapy by patients with very low risk disease, and increased intensity of chemotherapy for those with biological features that suggest a higher risk of relapse despite historically good risk characteristics. It is available to patients under the age of 30 with newly-diagnosed Stage III favorable histology Wilms 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 212-305-8615.
Kidney
ID:AAAC0905
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
AREN0321, Treatment of High Risk Renal Tumors, A Groupwide Phase II Study
This study examines the efficacy of a more intense chemotherapy regimen for young patients with high-risk kidney tumors. Patients are eligible to enroll if they are under thirty years of age an have a new diagnosis of Focal Anaplastic Wilms Tumor, Diffuse, Anaplastic Wilms Tumor, Clear Cell Sarcoma of Kidney, Malignant Rhabdoid Tumor, or Renal Cell Carcinoma of any stage.; 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 212-305-8615.
Kidney
ID:AAAC6186
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
AREN0533, Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
This protocol will investigate two separate strategies for risk stratification for patients with Stage III and IV Favorable Histology Wilms Tumor. The first is the identification of patients with pulmonary nodules who can be spared bilateral pulmonary irradiation. Patients with Stage IV favorable histology Wilms tumor have a 4 year event free survival (EFS) of 75% with chemotherapy and irradiation to sites of metastatic disease (most frequently in the lungs). European investigators are able to spare 75% of theirpatients with pulmonary nodules from irradiation based on the initial response to chemotherapy. This study will use the response of the lung metastases to 6 weeks of chemotherapy consisting of vincristine, dactinomycin, and doxorubicin (Regimen DD4A) to determine if radiation of lung nodules is needed. Patients who have complete disappearance of their lung metastases (or who have tissue confirmation thatthe nodules do not contain viable tumor) at the Week 6 evaluation will be considered rapid responders and will continue with DD-4A. Patients who do not have complete resolution of pulmonary nodules by Chest CT will undergo pulmonary irradiation and will be switched to Regimen M (DD4A variation with dactinomycin and doxorubicin given on the same day plus cyclophosphamide and etoposide). 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 212-305-8615.
Kidney
ID:AAAI1747
Industry
Principal Investigator: Dr. Edward Gelmann
Adult:
An open-label, multicenter Phase 1b/2 study of E7080 alone, and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment
The main purpose of this study is to look at the effects (good and/or bad) of E7080 in combination with everolimus on you and your renal cell cancer and to see what is the highest combination dose that can be given safely. It is not known what effect the combination of E7080 and everolimus will have on your disease or what the side-effectswill be when the two drugs are given together. If we can find a safe dose of everolimus and E7080 to give in combination, in the next part of this study and future studies, we can then go on to look at how the combination is tolerated and affects your cancer compared to everolimus on its own.In this study, you will receive either E7080 on its own, everolimus on its own, or both E7080 and everolimus together. The two study drugs are thought to work by inhibiting two different possible ways in which a tumor cell can grow and spread. It is possible that by giving the two study drugs at the same time, the effect on your cancer and survival may or may not be the same as giving each of the drugs on its own. E7080, the Study Drug, is an Investigational study drug. Investigational means that the drug being tested in this study has not been approved by the United States Food and Drug Administration (FDA). Everolimus (also known as Afinitor) is a drug approved by the FDA for the treatment of advanced renal cell carcinoma.You have been asked to participate in both parts of this study. The first part of this study will be done in approximately 6 research centers in the United States to determine the highest dose of E7080 and everolimus together that can be given safely. Approximately 30 subjects with your type of cancer will be enrolled in this part of the study. Afterwards,the second part of this study will enroll about 150 subjects with your type of cancer from about 50 research centers in the United States and Europe. Approximately 510 subjects will be enrolled at Columbia University Medical Center.The whole study will take about 36 months to complete. The results from this study should be known approximately 24 months after the last subject is enrolled. 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 212-305-8615.
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 212-305-8615.
Bones and Joints, Brain and Nervous System, Kidney, Soft Tissue
ID:AAAF3228
Externally Peer Reviewed
Principal Investigator: Dr. Stephen Sands
Pediatrics:
Periactin study (HLMCC 0703): Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
The main purpose of this study is to compare the effects of a medicine called cyproheptadine hydrochloride (CH) to placebo (no active medicine) on weight loss and malnourishment during cancer treatment. Researchers hope to determine whether cyproheptadine hydrochloride (CH) helps nutritional status in children with cancer. In this study, subjects will get either cyproheptadine hydrochloride (CH) or placebo (no active drug). Blood will be drawn and height and weight measurements will be taken. Subjects will be asked to keep a log of the times the drug is taken and any side effects they experience. They will be randomized into one of the study groups. Randomization means that you are put into a group by chance. One group of patients will be randomized to receive cyproheptadine hydrochloride (CH) to take by mouth 2 times a day for up to 8 weeks. The other group of patients will be randomized to receive a placebo (no active drug) to take by mouth 2 times a day for up to 8 weeks.About 178 people will take part in the overall study, and approximately 10 patients will enroll per year at Columbia University Medical Center. This study will last a maximum of eight 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 212-305-8615.
Kidney, Bladder
ID:AAAI0285
Industry
Principal Investigator: Dr. Edward Gelmann
Adult:
An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy.
This is an Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy The main purpose of this study is to gather information about the efficacy of the use of two investigational drugs called ramucirumab drug product (ramucirumab DP) and IMC-18F1 when each agent is administered in combination with a chemotherapy called docetaxel. Being part of this study may or may not make you better. You will only be included in this study if you choose to participate voluntarily. 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 212-305-8615.
Kidney, Other Urinary, Prostate, Bladder
ID:AAAE9906
Cooperative Group
Principal Investigator: Dr. Edward Gelmann
Adult:
A RANDOMIZED DOUBLE-BLINDED PHASE III STUDY COMPARING GEMCITABINE, CISPLATIN, AND BEVACIZUMAB (IND #7921, NSC #704865) TO GEMCITABINE, CISLPATIN, AND PLACEBO IN PATIENTS WITH ADVANCED TRANSITIONAL CELL CARCINOMA
This is a randomized, multi-center double-blinded phase III research study.The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on subjects with transitional cell cancer of the urinary tract to find out which is better. Bevacizumab is an antibody that may block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of this cancer and allow subjects to live longer. The National Cancer Institute (NCI) will provide Bevacizumab free of charge to subjects who are participating in 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 212-305-8615.
Kidney
ID:AAAF0256
Cooperative Group
Principal Investigator: Dr. Alice Lee
Adult:
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 212-305-8615.
Kidney, Liver, Soft Tissue, Thyroid
ID:AAAJ4351
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
ADVL1121: A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib
(IND# 69896) in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms
Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma
This is a phase II, multi-center study of Sorafenib, an agent that acts as a control in tumor growth. The purpose of this study is to determine the response rate to as well as evaluate the toxicities of Sorafenib in children and young adults with relapsed (cancers that have come back after being treated before) Rhabdomyosaroma, Wilma Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma. Sorafenib will be given every 12 hours as tablets. The therapy will last up to 28 days and the doctor may ask you to visit after to complete follow-up tests. Participants can receive up to 24 cycles of therapy continuously. There will be about 80 patients participating in this study overall and about 6 will be treated at Columbia University Medical Center. 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 solid 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 212-305-8615.
| 
