Actively Recruiting
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Led by Nabil Adra · Updated on 2026-05-08
64
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization
- Age 18 years or older at consent
- Diagnosis of non-seminomatous germ cell tumor
- Relapsed disease after initial cisplatin-based chemotherapy
- Completed salvage treatment with 2 cycles of HDCT and PBSCT
- HDCT as initial salvage chemotherapy (2nd line therapy); prior 1 or 2 standard regimens accepted
- Normal or decreasing AFP and hCG tumor markers at screening
- Adverse events from prior treatments recovered to CTCAE v5.0 grade 2 or less
- Women with ovarian germ cell tumors eligible
- ECOG performance status 0, 1, or 2 within 28 days before registration
- Last HDCT dose within 16 weeks before registration
- Adequate organ function based on lab values within 28 days before registration
- Negative pregnancy test within 28 days before first study drug dose for women of childbearing potential
- Agreement to use two forms of highly effective contraception or abstain from heterosexual activity for 30 days after last dose
You will not qualify if you...
- Diagnosis of relapsed pure seminoma
- Rising AFP or hCG tumor markers at screening
- More than 16 weeks since last HDCT dose
- Treatment with investigational agents within 28 days before registration
- Active malignancy requiring treatment in past 12 months
- Psychiatric illness or social situations limiting study compliance
- Active infection needing systemic therapy
- Previous hypersensitivity to etoposide not resolved
- Pregnancy, lactation, or breastfeeding
- Any condition or abnormality that may interfere with study participation or results, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
C
Christin Snow, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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