Study on Maintenance Treatment with Zanzalintinib and Etoposide After High-Dose Chemotherapy in Germ Cell Tumors

Sponsor: Indiana University

Sponsor score: 0

ClinicalTrials ID:NCT06937866

Provider View

This clinical trial is testing a new maintenance treatment using the drug zanzalintinib combined with etoposide for patients with relapsed germ cell tumors (GCT) who have already undergone high-dose chemotherapy and stem cell transplant. The study aims to evaluate the safety and effectiveness of this combination.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new treatment using zanzalintinib and etoposide in patients with relapsed germ cell tumors (GCT) who have already received high-dose chemotherapy and stem cell transplant. The study will start with a small group of patients to determine the best dose and monitor for any side effects. Participants will take zanzalintinib and etoposide orally in cycles, with treatment continuing until the cancer progresses or side effects become too severe.

Description

This study is designed to evaluate a new maintenance treatment for patients with relapsed germ cell tumors (GCT) who have already undergone high-dose chemotherapy and stem cell transplant. The trial will begin with a small group of 9 patients to test different doses of zanzalintinib for safety. Participants will take zanzalintinib daily along with etoposide for 21 days in a 28-day cycle. The study will use a specific design to find the maximum tolerated dose.

Inclusion criteria for Phase I include having a type of germ cell tumor that has not responded to previous treatments and is considered incurable with standard therapies. For Phase II, patients must have non-seminomatous GCT, have relapsed after initial chemotherapy, and completed high-dose chemotherapy and stem cell transplant. All participants must be adults, able to understand the study, and meet specific health criteria, including adequate blood counts and organ function. Women of childbearing potential must not be pregnant and must use effective contraception during the study.

Exclusion criteria include having received certain treatments recently, having other active cancers, or having significant health issues that could interfere with the study. Patients with known brain metastases or those requiring certain medications are also excluded. The study aims to provide valuable insights into whether this new combination treatment can help manage relapsed GCT.

Eligibility Criteria

Inclusion Criteria

  • Have a type of germ cell tumor that has not responded to previous treatments and is considered incurable with standard therapies.
  • For Phase II, must have non-seminomatous GCT and have relapsed after initial chemotherapy.
  • Completed high-dose chemotherapy and stem cell transplant.
  • Be 18 years or older.
  • Be able to understand and comply with the study requirements.
  • Have adequate blood counts and organ function.
  • Women of childbearing potential must not be pregnant and must use effective contraception during the study.

Exclusion Criteria

  • Have not received at least one salvage treatment regimen or have other potentially curative treatment options.
  • Have relapsed pure seminoma.
  • Have rising tumor markers at the time of screening.
  • Have received certain treatments recently, such as other cancer therapies or radiation.
  • Have known brain metastases unless adequately treated and stable.
  • Have significant health issues that could interfere with the study, such as uncontrolled heart conditions or active infections.
  • Be pregnant or breastfeeding.
  • Have a history of severe allergic reactions to study medications.

Locations

FACILITYZIPCITYSTATE
Indiana University Melvin and Bren Simon Comprehensive Cancer Center46202IndianapolisIndiana

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