Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

Not Recruiting

Trial ID: NCT00335556


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 different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Official Title

Treatment of High Risk Renal Tumors: A Groupwide Phase II Study

Stanford Investigator(s)


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

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


biological: dactinomycin

drug: carboplatin

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

drug: irinotecan hydrochloride

drug: vincristine sulfate

procedure: conventional surgery

radiation: radiation therapy

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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