NCT00335556

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00335556

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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

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

Disease(s) and\or Condition(s)

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

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Doxorubicin Hydrochloride
- Description: Given IV
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (regimen DD-4A), Treatment (regimen I), Treatment (window/UH-1)
- Type: DRUG
- Name: Irinotecan Hydrochloride
- Description: Given IV
- Arm Group Labels: Treatment (UH-2), Treatment (window/UH-1)
- Type: PROCEDURE
- Name: Conventional Surgery
- Description: Patients undergo resection
- Arm Group Labels: Surgery, Treatment (UH-1), Treatment (UH-2), Treatment (regimen DD-4A), Treatment (regimen I), Treatment (window/UH-1)
- Type: DRUG
- Name: Cyclophosphamide
- Description: Given IV
- Arm Group Labels: Treatment (UH-1), Treatment (regimen I), Treatment (window/UH-1)
- Type: DRUG
- Name: Etoposide
- Description: Given IV
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (regimen I), Treatment (window/UH-1)
- Type: DRUG
- Name: Carboplatin
- Description: Given IV
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (window/UH-1)
- Type: BIOLOGICAL
- Name: Dactinomycin
- Description: Given IV
- Arm Group Labels: Treatment (regimen DD-4A)
- Type: DRUG
- Name: Vincristine Sulfate
- Description: Given IV
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (regimen DD-4A), Treatment (regimen I), Treatment (window/UH-1)
- Type: RADIATION
- Name: Radiation Therapy
- Description: Undergo radiotherapy
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (regimen DD-4A), Treatment (regimen I), Treatment (window/UH-1)
- Type: OTHER
- Name: Laboratory Biomarker Analysis
- Description: Correlative studies
- Arm Group Labels: Treatment (UH-1), Treatment (UH-2), Treatment (regimen DD-4A), Treatment (regimen I), Treatment (window/UH-1)

Sponsor

Children's Oncology Group