Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT

Recruiting Phase 2 Interventional Study
Germ Cell Tumor Non-seminomatous Germ Cell Tumor Ovarian Germ Cell Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Nabil Adra · Other
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About This Trial

This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information 2. Age ≥ 18 years at the time of consent 3. Histological or serological evidence of non-seminomatous GCT 4. Relapsed disease after first-line cisplatin-based combination chemotherapy 5…
Contacts

Christin Snow, RN

317-274-5830

chsnow@iu.edu

CONTACT