Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Condition: Childhood Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; Clear Cell Sarcoma of the Kidney; Papillary Renal Cell Carcinoma; Rhabdoid Tumor of the Kidney; Stage I Renal Cell Cancer; Stage I Renal Wilms Tumor; Stage II Renal Cell Cancer; Stage II Renal Wilms Tumor; Stage III Renal Cell Cancer; Stage III Renal Wilms Tumor; Stage IV Renal Cell Cancer; Stage IV Renal Wilms Tumor
MeSH terms: Carcinoma; Neoplasms; Carcinoma, Renal Cell; Wilms Tumor; Rhabdoid Tumor; Sarcoma, Clear Cell; Kidney Neoplasms
Intervention: Doxorubicin Hydrochloride; Irinotecan Hydrochloride; Conventional Surgery; Cyclophosphamide; Etoposide; Carboplatin; Dactinomycin; Vincristine Sulfate; Radiation Therapy; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IV; Patients undergo resection; Given IV; Given IV; Given IV; Given IV; Given IV; Undergo radiotherapy; Correlative studies
Intervention MeSH terms: Dactinomycin; Cyclophosphamide; Carboplatin; Doxorubicin; Liposomal doxorubicin; Irinotecan; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 291.0
Sex: All
Maximum age: 29 Years
Healthy volunteers: No

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 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.
    

Eligibility criteria:

        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