Clinical Trial: Cancer

Wilms Tumor Study

Full Name

Wilms Tumor (COG #AREN0534): Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Group-wide Phase III Study (1_PRO00000569 - CIRB)

Description

Participants on the study will begin treatment with 6 weeks of chemotherapy (2 cycles of 3 weeks each). The type of cells in the tumor and the stage of the participant’s disease will determine the chemotherapy treatment to be used. For the first 2 cycles, participants will receive one of two different chemotherapy regimens. The drugs used in these regimens are commonly used to treat Wilms tumor. In general, if the participant has low stage disease with less aggressive cancer cells, they will get the 3 drug regimen consisting of vincristine, dactinomycin, and doxorubicin (often called "VAD"). After two cycles, participants will be evaluated. The evaluation includes CT or MRI scans, and often a biopsy to see if the tumor(s) has/have been affected by the chemotherapy. After the evaluation, participants could receive: 1) more chemotherapy with the same set of drugs; 2) more chemotherapy with a different set of drugs; 3) surgery, then more chemotherapy with the same set of drugs; 4) surgery, then more chemotherapy with a different set of drugs; 5) surgery, then radiation therapy and more chemotherapy with the same set of drugs; or 6) surgery, then radiation therapy and more chemotherapy with a different set of drugs. The regimens used in this study will last from 18 to 43 weeks. After treatment, participants will have follow-up examinations and medical tests. The researchers will collect information about how the participants are doing for about 10 years after they enter the study. Participants will have a kidney ultrasound performed every 3 months for five years or until age 8, whichever comes first.

Eligibility

Inclusion Criteria

o Must be enrolled on AREN03B2 prior to enrollment on this study
o Must be less than 30 years old at the time of initial diagnosis
o Must not have received systemic chemotherapy or radiation therapy prior to treatment on this study
o Must have adequate liver and cardiac function
o Females of childbearing age must have a negative pregnancy test