A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Conditions

• Anaplastic Kidney Wilms Tumor
• Recurrent Kidney Wilms Tumor
• Stage II Kidney Wilms Tumor
• Stage III Kidney Wilms Tumor
• Stage IV Kidney Wilms Tumor

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo a biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Scan — PROCEDURE
  Undergo a bone scan
• Carboplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo a CT scan
• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Ifosfamide — DRUG
  Given IV
• Irinotecan — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo a PET scan
• Radiation Therapy — RADIATION
  Undergo RT
• Surgical Procedure — PROCEDURE
  Undergo surgery
• Topotecan — DRUG
  Given IV
• Transabdominal Ultrasound — PROCEDURE
  Undergo abdominal ultrasound
• Vincristine — DRUG
  Given IV
• X-Ray Imaging — PROCEDURE
  Undergo a chest x-ray

Study 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 WT).

Key Dates

Start date

Oct 19, 2020

Status verified

Mar 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

256 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (Regimen UH-3)
  See outline in detailed description section.
• Experimental: Arm II (Regimen ICE/Cyclo/Topo)
  CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.

Primary Outcome Measure

Event-free survival (EFS) for stratum 1-3 [ Time Frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years from study entry ]

Locations (177)

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