Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
* Determine the safety of this drug in these patients.
OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
* Measurable metastatic disease by one of the following methods:
* Radiography
* If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
* Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
Previously treated progressive disease meeting 1 of the following criteria:
* Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
* Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
