Status:
COMPLETED
Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in differen...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide (regi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed disease of 1 of the following histologic types:
- Focal anaplastic Wilms' tumor
- Diffuse anaplastic Wilms' tumor
- Clear cell sarcoma of the kidney
- Malignant rhabdoid tumor (renal or extrarenal)
- Renal cell carcinoma
- Clear cell
- Papillary
- Renal medullary
- Oncocytoid
- Sarcomatoid
- Chromophobe
- Translocation
- Collecting duct
- Carcinoma associated with neuroblastoma
- Renal cell carcinoma unclassified
- Specimens/materials must be submitted for central review by Day 7
- Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
- Karnofsky performance status (PS) must be \>= 50 for patients \> 16 years if age and Lansky PS must be \>= 50 for patients =\< 16 years of age
- Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study
- Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ ALT\]) \< 2.5 times ULN for age
- Shortening fraction of \>= 27% by echocardiogram OR ejection fraction of \>= 50% by radionuclide angiogram
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding
- Sexually active patients of childbearing potential must agree to use effective contraception
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00335556
Start Date
June 1 2006
Last Update
July 21 2017
Active Locations (187)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
3
University of South Alabama
Mobile, Alabama, United States, 36604
4
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016