Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors
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.
Interventional
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
No
Lawrence H Einhorn, MD
Principal Investigator
Indiana University School of Medicine
United States: Food and Drug Administration
IUCRO-0403
NCT01808534
February 2013
September 2015
Name | Location |
---|---|
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 |