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

Open to males ages 18 years and up

• Histologically confirmed adenocarcinoma of the prostate
• Age greater than18 years
• Rising serum PSA levels documented by 3 values over the last 6 months prior to study enrollment. Each value must be greater than 2 weeks from the previous value.
• Patients with rising PSA must have had either 1) prior definitive therapy including surgery or radiation therapy (hormone-naïve, defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL), or 2) hormone suppressive therapy as documented by surgical castration or a serum testosterone value less than 50 ng/dL(hormone-independent). Patients must have completed these therapies for at least 6 months but no longer than 20 years prior to enrollment
• PSA value within 4 weeks of starting therapy less than 20 ng/mL for hormone-naïve patients (defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL) or less than 60 ng/mL for hormone-independent patients.
• Patients must have the following laboratory values: ANC greater than 1500/mcL,platelet count greater than 100,000/mcL, hemoglobin greater than 10 g/dL, bilirubin less than 1.5 x upper limits of normal, AST less than 1.5 x upper limits of normal
• Patients must have adequate lung function, as defined by oxygen saturation greater than or equal to 90% by pulse oximetry
• Patients must have QTc interval less than 450 msec
• Patients must have adequate EGFR greater than 30 mL/min per 1.73 m2 (per VA formula and adjusted for gender and race)
• Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include: a) surgical sterilization (subject and/or subject's partner), b) approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot), c) barrier methods (such as a condom or diaphragm) used with a spermicide, and d) an intrauterine device (IUD).