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

Clinical Trial Details

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 Wilms tumors).

Key Eligibility:

Patients must be ≤ 30 years old at study enrollment.
Newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor.
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study.
The relapse risk groups are defined as follows, regardless of radiation therapy:
- Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine.
- High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan.
- Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily Regimen M or its variations.

Patients with newly diagnosed DAWT must have histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Lisa Bayer, NP
(212) 746-3413
lbayer@med.cornell.edu

Primary Investigator(s)

Lisa Giulino Roth, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2103023457

ClinicalTrials.gov:

NCT04322318

Status

Open to Enrollment

Age Group

Adult , Pediatric

Disease

Kidney Cancer