Kidney Cancer Clinical Trial
Official title:
Nephroblastoma Clinical Trial and Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known which regimen of chemotherapy is more
effective for stage I Wilms' tumor.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery
in treating children who are at risk of or who have stage I Wilms' tumor.
OBJECTIVES: I. Determine the initial extension of disease, surgical procedures, gross and
histological morphology, treatments, clinical outcome, and late consequences of therapy
after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or
without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I
Wilms' tumor. II. Determine the safety and effectiveness of reduced chemotherapy in these
patients.
OUTLINE: This is a randomized, multicenter study. Patients receive dactinomycin IV on days
1-3 and 15-17 and vincristine IV on days 1, 8, 15, and 22. Patients then undergo surgery
about a week after completion of chemotherapy. After surgery, patients receive vincristine
IV on days 1, 8, 15, and 22 and dactinomycin IV on days 8-12. Patients are then randomized
to one of two treatment arms after week 9. Arm I: Patients receive dactinomycin IV on days
1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11. This course is repeated
during weeks 17 and 18. Arm II: Patients receive no further treatment. Patients are followed
every 3 months for 3 years, then annually thereafter. Peer Reviewed and Funded or Endorsed
by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this
study within 7-8 years.
;
Allocation: Randomized, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00541008 -
Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
|
Phase 2 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
Recruiting |
NCT00301990 -
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00467077 -
Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00098943 -
NGR-TNF in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT00899860 -
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer
|
N/A | |
Terminated |
NCT00089102 -
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00021021 -
RPI.4610 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
Completed |
NCT00006968 -
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
|
Phase 1/Phase 2 |