Study on Maintenance Oral Etoposide or Observation After High-Dose Chemotherapy for Relapsed Germ Cell Tumors

Sponsor: Nabil Adra

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04804007

Provider View

This clinical trial is comparing the effects of taking a maintenance dose of the drug etoposide by mouth versus just observation in patients who have had high-dose chemotherapy and stem cell transplant for relapsed germ cell tumors.

Patient Parameters

Program Overview

This study is testing whether taking a daily oral dose of the drug etoposide can help maintain health in patients who have had high-dose chemotherapy and a stem cell transplant for relapsed germ cell tumors. Participants will be randomly assigned to either take etoposide or be observed without additional treatment. The trial aims to see if etoposide can provide benefits in maintaining remission after intensive treatment.

Description

This clinical trial is designed to evaluate the effectiveness of maintenance therapy with oral etoposide compared to observation in patients who have undergone high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT) for relapsed germ cell tumors (GCT). Participants who have completed their HDCT and PBSCT within the last 16 weeks will be randomly assigned to either take a daily dose of 50mg oral etoposide or to be observed without additional treatment. The study aims to determine if the maintenance therapy can help in keeping the cancer in remission after the intensive treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Must have evidence of non-seminomatous germ cell tumors (GCT).
  • Must have relapsed after initial chemotherapy treatment.
  • Must have completed high-dose chemotherapy and stem cell transplant as per guidelines.
  • Must have normal or decreasing tumor markers (AFP and hCG) at screening.
  • Must have recovered from previous treatment side effects to a certain level.
  • Women with ovarian germ cell tumors can participate.
  • Must have a performance status score of 0, 1, or 2.
  • Last dose of high-dose chemotherapy must be within 16 weeks of joining the study.
  • Must have adequate organ function based on lab tests.
  • Male participants must agree to use contraception during and after the study.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception.

Exclusion Criteria

  • Cannot have relapsed pure seminoma.
  • Cannot have increasing tumor markers (AFP and hCG) at screening.
  • Cannot have completed high-dose chemotherapy more than 16 weeks ago.
  • Cannot have taken any investigational drugs within 28 days before joining the study.
  • Cannot have another active cancer needing treatment in the past year.
  • Cannot have psychiatric or social issues that would prevent following study requirements.
  • Cannot have an active infection needing treatment.
  • Cannot have had a severe allergic reaction to etoposide that did not improve with care.
  • Cannot be pregnant, breastfeeding, or lactating.
  • Cannot have any condition or treatment that might interfere with the study or not be in the participant's best interest.

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