Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors
I. To determine the response rate (complete response [CR]+partial response [PR]) of single
agent palifosfamide in patients with refractory germ cell tumors.
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
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
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
Rate of response (CR+PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and/or serum tumor markers (alpha fetoprotein and beta-hCG)
Summarized in the evaluable population by proportions with 90% confidence intervals.
Up to 5 years
Lawrence H Einhorn, MD
Indiana University School of Medicine
United States: Food and Drug Administration
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Virginia Mason Medical Center||Seattle, Washington 98111|