NCT00274287

GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere

A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oncology Specialists, S.C. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.

Detailed description

Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	GM CSF	250 ug/m2 daily for 2 weeks followed by 2 weeks of rest

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-01-10
• Last updated: 2019-03-28
• Results posted: 2012-05-09

Locations

1 site across 1 country: United States