Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-04-13 @ 5:13 PM
Study NCT ID:
NCT01808534
Status:
TERMINATED
Last Update Posted:
2015-07-02
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Sponsor:
Indiana University School of Medicine
Organization:
Study Overview
Official Title:
Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: