Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
Nabil Adra
Summary
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).
Description
This is a randomized phase 2 trial of maintenance etoposide versus observation following HDCT+PBSCT for relapsed GCT. Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion to maintenance daily oral etoposide 50mg vs. observation only.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines 6. HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \[vin…
Interventions
- DrugEtoposide
etoposide will be provided with prescription for etoposide 50mg orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles.
Location
- Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Indiana