Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNabil Adra
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).
Eligibility criteria
Qualifiers
Written informed consent and HIPAA authorization for release of personal health information
Age ≥ 18 years at the time of consent
Histological or serological evidence of non-seminomatous GCT
Relapsed disease after first-line cisplatin-based combination chemotherapy
Disqualifiers
Relapsed pure seminoma
Rising tumor markers (AFP and hCG) at time of screening
Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) >16 weeks ago
Treatment with any investigational agent within 28 days prior to study registration
Trial design
Treatments tested in this trial
- Etoposide
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nabil Adra
Lead sponsor
Indiana University
Sponsor institution
Source ClinicalTrials.gov