Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
Children's Oncology Group
Summary
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Description
PRIMARY OBJECTIVES: I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the event-free survival (EFS) of patients with newly diagnosed stage 4 diffuse anaplastic Wilms tumor (DAWT) as compared to historical controls. II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS of patients with standard-risk relapsed favorable histology Wilms tumor (SRrFHWT)…
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor. * Patients must be =\< 30 years old…
Interventions
- ProcedureBiopsy Procedure
Undergo a biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo a bone scan
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo a CT scan
- DrugCyclophosphamide
Given IV
- DrugDoxorubicin
Given IV
Locations (204)
- Children's Hospital of AlabamaBirmingham, Alabama
- USA Health Strada Patient Care CenterMobile, Alabama
- Providence Alaska Medical CenterAnchorage, Alaska
- Banner Children's at DesertMesa, Arizona
- Phoenix Childrens HospitalPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona