Recurrent Ovarian Germ Cell Tumor Clinical Trial
Official title:
Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors
This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
PRIMARY OBJECTIVES:
I. To determine the response rate (complete response [CR]+partial response [PR]) of single
agent palifosfamide in patients with refractory germ cell tumors.
SECONDARY OBJECTIVES:
I. To determine the duration of remission. II. To determine progression free and overall
survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ
cell tumors.
OUTLINE:
Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years,
every 6 months for 2 years, and then annually thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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