Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Adult Central Nervous System Germ Cell Tumor
Malignant Extragonadal Germ Cell Tumor
Malignant Extragonadal Non-Seminomatous Germ Cell Tumor
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor
Stage IV Extragonadal Seminoma
Stage IV Ovarian Germ Cell Tumor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors|
- Overall Response Rate (Defined as Partial Response or Complete Response) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.
- Duration of Remission in Patients Who Achieve a Partial or Complete Response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.
- Progression Free Survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.
- Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.
- Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
|Study Start Date:||February 2013|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (palifosfamide)
Patients receive palifosfamide 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.
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 cell tumors.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808534
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|Abramson Cancer Center of The University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Lawrence H Einhorn, MD||Indiana University School of Medicine|