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Investigator(s):
Jay A. Berzofsky, M.D., Ph.D. Principal Investigator Phone: 301-496-6874 Fax: 301-480-0681 berzofsk@helix.nih.gov	Lauren V. Wood, M.D. Lead Associate Investigator Phone: 301-402-0199 woodl@mail.nih.gov
Referral Contact(s):
Brenda Roberson, R.N., O.C.N. Research Nurse Phone: 301-435-4733 broberson@mail.nih.gov

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Primary Eligibility:

• Males ≥ 18 years of age with histologically confirmed adenocarcinoma of the prostate
• HLA-A*201-positive
• Stage D0 disease with documented biochemical progression documented by a rising PSA
• Must have completed all prior definitive therapy or other definitive-intent local therapy for the primary tumor and recovered
• A rise in PSA of > 2 ng/mL above the nadir for patients who underwent definitive radiation therapy or cryotherapy
• Two absolute PSA values > 0.3 ng/mL for patients who underwent radical prostatectomy
• Baseline prostate-specific antigen doubling time (PSADT) > 3 months and < 15 months:
• Must have ≥ 3 PSA measurements over ≥ 3 months
• The interval between PSA measurements must be ≥ 4 weeks
• Normal level of testosterone (prior androgen-deprivation therapy allowed)
• No brain, visceral, or bony metastatic disease by physical examination, CT scan, and bone scan
• Recovered from previous therapy
• No prior prostate cancer vaccines
• No concurrent pharmacologic doses of immune-modulating agents
• No concurrent medications used for urinary symptoms (chronic stable doses of medications for urinary symptoms that do not alter 5-alpha reductase inhibitors allowed)
• ECOG performance status (PS) 0–2 OR Karnofsky PS 70–100%
• Hemoglobin ≥ 10 g/dL
• WBC ≥ 3,000/mm³
• Absolute lymphocyte count ≥ 800/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• PT/PTT ≤ 1.5 x upper limit of normal (ULN)
• SGOT and SGPT ≤ 2.5 x ULN
• Total bilirubin < 1.5 x ULN
• Creatinine < 1.5 x ULN
• Estimated glomerular filtration rate > 60 mL/min
• Hepatitis B and C negative (unless result is consistent with prior vaccination or infection with full recovery)
• HIV negative
• No active second malignancy, other than adequately treated squamous cell or basal cell carcinoma of the skin or superficial bladder carcinoma
• No use of investigational agents within 4 weeks of study enrollment
• No medical condition that would preclude study participation

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Study Outline:

Patients are randomized to one of two treatment arms.

Arm A:

• Patients receive vaccine comprising wild-type and epitope-enhanced TARP peptides with Montanide^® ISA-51 VG and sargramostim subcutaneously on Weeks 3, 6, 9, 12, and 15*

Arm B

• Patients receive vaccine comprising autologous TARP peptide-pulsed dendritic cells intradermally on Weeks 3, 6, 9, 12, and 15*

• Patients undergo PSADT response assessment at baseline and at Weeks 12, 24, 36, and 48
• Patients undergo apheresis at Weeks 0, 24, and 48 and immunogenicity, safety and toxicity monitoring at each study visit
• Patients will also receive intranasal FluMist influenza vaccine (when available) as a control vaccine at Week 0 to assess their inherent ability to generate CD8+ T cell responses to vaccination

*Patients who achieve PSA doubling time (PSADT) response at Week 24 (i.e., ≥ 50% increase in calculated PSADT OR PSADT > 15 months) may receive an additional dose of TARP peptide vaccine at Week 36.

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 9/8/09