Full TitleA Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors (Alliance A031102) (CIRB)
The purpose of this study is to compare a conventional chemotherapy regimen for relapsed germ cell tumors with a high-dose regimen to see if the high-dose chemotherapy is more effective. These treatments are being assessed in male patients with germ cell tumors that came back or continued to grow after their first regimen of chemotherapy.
The conventional chemotherapy includes four cycles of the drugs paclitaxel, ifosfamide, and cisplatin. The high-dose treatment includes two cycles of paclitaxel and ifosfamide, followed by three cycles of much higher doses of the drugs carboplatin and etoposide with a stem cell transplant. Patients’ stem cells are removed before beginning carboplatin/etoposide treatment and then returned to them after each cycle of carboplatin/etoposide.
Patients in this study will be randomly assigned to receive either conventional chemotherapy or the high-dose chemotherapy regimen, but not both. All patients will also receive medication to support their white blood cell counts.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- This study is for male patients age 14 and older.
- Patients must have a germ cell tumor that came back or continued to grow despite one prior regimen of chemotherapy that contained cisplatin.
- Patients must recover from the serious side effects of previous treatment before entering the study.