Clinical Trials Directory

Trials / Terminated

TerminatedNCT01808534

Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors

Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Indiana University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGpalifosfamideGiven IV

Timeline

Start date
2013-02-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2013-03-11
Last updated
2015-07-02
Results posted
2015-07-02

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01808534. Inclusion in this directory is not an endorsement.