Study on Combination Chemotherapy for Newly Diagnosed and Relapsed Wilms Tumors

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04322318

Provider View

This clinical trial is testing how well a combination of chemotherapy drugs works for patients with newly diagnosed or relapsed Wilms tumors, a type of kidney cancer. The study aims to find out if these drug combinations can effectively stop tumor growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combination chemotherapy in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) and those with favorable histology Wilms tumors (FHWT) that have relapsed. The chemotherapy regimens being tested include drugs like vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, irinotecan, ifosfamide, and topotecan. These drugs work in different ways to stop tumor cells from growing, dividing, or spreading. The trial will help doctors understand the effects of these treatments on patients with different types of Wilms tumors.

Description

The main goals of this study are to see if adding certain chemotherapy drugs can improve the time patients live without their cancer getting worse (event-free survival) and their overall survival. The study is divided into two groups:

  • Group 1 (Regimen UH-3): Patients receive a combination of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan in cycles. Radiation therapy may also be given as needed. Various scans and tests will be conducted throughout the trial to monitor the cancer.

  • Group 2 (Regimen ICE/Cyclo/Topo): Patients receive a combination of ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan in cycles. Surgery and radiation therapy may be performed as needed. Scans and tests will be conducted to track the cancer's response.

After completing the treatment, patients will have follow-up visits every 3 months for the first 2 years, every 6 months for the next 2 years, and once in the fifth year to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Patients with newly diagnosed stage 2-4 diffuse anaplastic Wilms tumor (DAWT) or relapsed favorable histology Wilms tumor (FHWT).
  • Must be 30 years old or younger at the time of enrollment.
  • Patients with newly diagnosed DAWT must have had a biopsy or surgery confirming the diagnosis.
  • Patients with relapsed FHWT must have previously achieved remission for their initial diagnosis.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have a life expectancy of at least 8 weeks.
  • Must meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.

Exclusion Criteria

  • History of bilateral Wilms tumor.
  • Uncontrolled illness, such as active infection or heart failure.
  • Relapsed FHWT patients who did not receive initial chemotherapy or received only one chemotherapy agent.
  • Patients with high-risk relapsed FHWT and certain kidney conditions.
  • Patients with chronic inflammatory bowel disease or bowel obstruction.
  • Use of St. John's wort, which cannot be stopped before treatment.
  • Pregnant or breastfeeding women.
  • Sexually active patients not using effective contraception.

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