OncoMatch/Clinical Trials/NCT04322318
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Is NCT04322318 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for anaplastic kidney wilms tumor.
Treatment: Carboplatin · Cyclophosphamide · Doxorubicin · Etoposide · Ifosfamide · Irinotecan · Topotecan · Vincristine — 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).
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage II, III, IV
Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy (actinomycin D, vincristine) — frontline
Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
Must have received: chemotherapy (vincristine, actinomycin D, doxorubicin) — frontline
High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
Must have received: chemotherapy (vincristine, actinomycin D, irinotecan) — frontline
High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
Must have received: chemotherapy — frontline
Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
Cannot have received: chemotherapy
Exception: Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for presumed FHWT, or no more than 6 weeks of chemotherapy following upfront biopsy for presumed FHWT, or emergent vincristine/doxorubicin/cyclophosphamide within allowed timing, or radiation as part of standard of care for presumed FHWT prior to identification of diffuse anaplasia are eligible
Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations: ... (see above for exceptions)
Cannot have received: chemotherapy
Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis
Cannot have received: myelosuppressive chemotherapy
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
Cannot have received: radiation therapy
Exception: Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
Radiation therapy (RT): >= 2 weeks must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation
Cannot have received: investigational agents
Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
Lab requirements
Blood counts
ANC >= 750/uL; Platelet count >= 75,000/uL (transfusion independent); Hemoglobin >= 8.0 g/dL (may receive RBC transfusions)
Kidney function
Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment); or age-based maximum serum creatinine (see table in protocol)
Liver function
Total bilirubin <= 1.5 x ULN for age or direct bilirubin <= ULN for patients whose total bilirubin > 1.5 x ULN; AST/ALT < 2.5 x ULN for age or <= 5 x ULN for patients with liver metastases
Cardiac function
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
Peripheral absolute neutrophil count (ANC) >= 750/uL; Platelet count >= 75,000/uL (transfusion independent); Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions); Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 ... or an adequate serum creatinine as per the following table; Total bilirubin <= 1.5 x ULN for age or direct bilirubin <= ULN for patients whose total bilirubin > 1.5 x ULN; AST/ALT < 2.5 x ULN for age or <= 5 x ULN for patients with liver metastases; Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- USA Health Strada Patient Care Center · Mobile, Alabama
- Providence Alaska Medical Center · Anchorage, Alaska
- Banner Children's at Desert · Mesa, Arizona
- Phoenix Childrens Hospital · Phoenix, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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