Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients

PHASE1UnknownINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

PSA/IL-2/GM-CSF

"In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15.~In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43."

Trial Locations (1)

92161

VA San Diego Healthcare System, San Diego

Sponsors
All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

OncBioMune Pharmaceuticals

OTHER