A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Phase II trial testing new chemotherapy combinations for children with Wilms tumor, including newly diagnosed DAWT and relapsed FHWT at different risk levels.
About
Protocol Description
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). 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).
COG# AREN1921
Eligibility Criteria
Inclusion Criteria
- All patients must be enrolled on APEC14B and consent to Part A – Eligibility Screening
- All patients must be < than 30 at the time of enrollment
- Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor
- Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible
- Adequate liver and cardiac function
Exclusion Criteria
- Patient with a diagnosis of Stage V Bilateral Wilms Tumor
- Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
- Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
- Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor
- Prior therapy or concurrent therapy
- Pregnant and breastfeeding patients are not eligible
Primary Investigator
Dr. Glenn Edwards is the Section Chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's Principal Investigator for Carilion Clinic. He has more than 30 years of clinical experience. He's board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, CCRP
Clinical Research Coordinator II
Sydnee Moses, BS
Clinical Research Coordinator II
