At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Docetaxel, and 6 other interventions for Testicular Cancer. Completed, enrolled 64 participants across 2 sites.
Detailed Summary
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied. This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors. Up to 67 patients will be enrolled in this study.
Study Details
Timeline
Interventions
1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem cell infusion on Day 0.