Trial Information

Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney (CCSK)

OBJECTIVES:

- Determine survival rates of patients with relapsed or refractory Wilms' tumor or clear
cell sarcoma of the kidney treated with chemotherapy followed by surgical resection and
adjuvant radiotherapy with or without autologous stem cell rescue.

- Determine the efficacy and toxicity of these regimens in these patients.

- Determine prognostic variables in patients treated with these regimens.

OUTLINE: Patients are assigned to one of three treatment regimens.

- Regimen A (patients with initial stage I tumors previously treated with vincristine
with or without dactinomycin with relapse at least 6 months after diagnosis): Patients
receive vincristine IV once weekly on weeks 1-10 and then every 3 weeks during weeks
11-52, dactinomycin IV every 3 weeks during weeks 1-52, and doxorubicin IV over 6 hours
every 3 weeks during weeks 1-34 (weeks 1-28 if pulmonary radiotherapy is planned).
Patients undergo surgical resection and radiotherapy after 6 weeks of therapy.

- Regimen B (patients with initial stage II tumors previously treated with vincristine
and dactinomycin with relapse at least 6 months after diagnosis): Patients receive
cyclophosphamide IV twice daily on days 1-2 and 22-23, etoposide IV over 1 hour on days
1-3, and doxorubicin IV over 6 hours on days 22 and 23. Treatment repeats every 42 days
for a total of 4 courses. Patients undergo surgical resection and radiotherapy after 2
courses of chemotherapy. Patients not achieving complete response after 4 courses of
chemotherapy undergo autologous bone marrow transplantation as in regimen C.

- Regimen C (all other patients in first relapses OR with progression on first-line
therapy OR in second or subsequent relapse previously treated on regimens A and B):
Patients receive carboplatin IV over 1 hour on day 1, etoposide IV over 2 hours on days
1-3 and 22-24, and cyclophosphamide IV twice daily on days 22 and 23. Treatment repeats
every 42 days for a total of 3 courses. Patients may undergo surgical resection prior
to stem cell rescue. Beginning within 6 weeks after completion of chemotherapy,
patients receive melphalan IV on day -1. Autologous peripheral blood stem cells or bone
marrow is reinfused on day 0. Patients undergo radiotherapy after transplantation.

Patients are followed every 8 weeks for 1 year, every 12 weeks for 1 year, and then every 6
months thereafter.

PROJECTED ACCRUAL: Approximately 75 patients (25 for regimens A and B and 50 for regimen C)
will be accrued for this study.