Clinical Trial Title Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Trial Status Closed to Enrollment
Start Date 07/24/2006
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Renal (High Risk)
Description 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 Enrollment on the AREN03B2 Renal Tumor Biology and Classification Study is required PRIOR to enrollment on the COG AREN0321

Age: <30 years old at the time of initial diagnosis

Newly diagnosed (Stages I-IV) of the following histological types are eligible
  • Focal Anaplastic Wilms Tumor
  • Diffuse Anaplastic Wilms Tumor
  • Clear Cell Sarcoma of Kidney
  • Malignant Rhabdoid Tumor (Renal or extra renal, excluding CNS tumors)
  • Renal Cell Carcinoma (clear cell, papillary, renal medullary, oncocytoid, sarcomatoid, chromophobe, translocation, collecting duct, carcinoma associated with neuroblastoma, renal cell carcinoma unclassified)

Patients must begin protocol therapy on COG AREN0321 by Day 14 after surgery or biopsy unless medically contraindicated

Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the COG AREN0532 or AREN0533 studies and received pre-nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor

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

Adequate liver and heart function
IRB Number

Study status is:
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone (503) 276-9300
Contact Fax
Contact E-Mail