AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This is a Phase 2 study of patients for the treatment of patients with high risk Wilms tumors (including those with diffuse anaplastic Wilms tumor- DAWT) and those who have relapsed favorable histology Wilms tumor (FHWT). The main goal of the study is to find out whether treatment with chemotherapy consisting of vincristine/irinotecan; cyclophosphamide/carboplatin/etoposide; and vincristine/doxorubicin/cyclophosphamide) improves the survival of patients with newly diagnosed Stage 4 diffuse anaplastic Wilms tumor (DAWT) or Standard-Risk relapsed favorable histology Wilms tumor (SRrFHWT) as compared to patients who were treated in the past. The study will also establish survival rates for High- Risk (HRrFHWT) and Very High-Risk (VHRrFHWT) relapsed favorable histology Wilms tumor patients treated with chemotherapy consisting of ifosfamide/carboplatin/etoposide and cyclophosphamide/ topotecan.

Are you Eligible? (Inclusion Criteria)

• Patient must be ≤ 30 years of age at the time of enrollment
• Patient must have Newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor (DAWT) or Favorable histology Wilms tumor at first relapse who previously achieved remission
• Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required.
• Patient must also meet all other eligibility criteria as outlined in the study protocol.