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

Summary

This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine. Eligible patients include those with recurrent prostate cancer as shown by elevated levels of PSA, although there is no evidence of tumors that are measurable by imaging studies. In addition, to be eligible patients must have prostate cancer that either has not been treated by hormonal therapy or is not responsive to hormonal therapy.

Timeline

Start

2012-04

Primary completion

2018-12

Completion

2018-12

Drugs

Indications