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A Phase I Trial of Sequential Paclitaxel/Ifosfamide and Dose-Intensive Paclitaxel, Carboplatin, and Dose-Escalated Ifosfamide with Stem Cell Support in Cisplatin- Resistant Germ Cell Tumor Patients
[Protocol 06-077]
- Full Title :
- PHASE I/II TRIAL OF SEQUENTIAL PACLITAXEL/IFOSFAMIDE FOLLOWED BY DOSE ESCALATED, DOSE-INTENSIVE CARBOPLATIN, PACLITAXEL AND IFOSFAMIDE WITH STEM CELL SUPPORT IN CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS
- Purpose :
The purpose of this study is to determine the safety and effectiveness of an intensive combination of chemotherapy drugs (paclitaxel, carboplatin, and ifosfamide) in patients with advanced germ cell tumors that do not response to cisplatin treatment. One group of patients will be treated with one dose level throughout their therapy. If this dose level is well tolerated, the other groups will be treated with higher doses of ifosfamide. Researchers aim to find the highest dose of ifosfamide that can be given safely in combination with paclitaxel and carboplatin.
All of these drugs have been used to treat patients with germ cell tumors that have persisted despite standard treatment. Moreover, high-dose chemotherapy regimens used with autologous stem cell transplantation have been shown to result in lasting remissions.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of an advanced germ cell tumor that has stopped responding to cisplatin chemotherapy.
- At least 3 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients may not have had a previous stem cell transplant.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Robert J. Motzer at 646-422-4312.
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