At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
GM CSFdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GM CSF for Prostate Cancer. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedJan 2006
Primary CompletionDec 2010
TodayJul 2026
First PostedJan 10, 2006
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.5 years ago
Interventions
GM CSFdrug
250 ug/m2 daily for 2 weeks followed by 2 weeks of rest