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Investigator(s):
James L. Gulley, M.D., Ph.D., F.A.C.P. Principal Investigator Phone: 301-435-2956 gulleyj@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Mary Pazdur, C.R.N.P. Nurse Practitioner Phone: 301-496-7870 Fax: 301-480-5094 pazdurm@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed prostate cancer
  • Metastatic androgen independent disease with at least 2 bone lesions consistent with prostate cancer metastasis
  • Progressive disease defined by 1 of the following criteria:
    • Two rising PSA values separated by ≥ 1 week
    • New or enlarging lesions consistent with prostate cancer
    • Clinical progression
• Previously treated with docetaxel for metastatic disease, unless unable to tolerate docetaxel
• Concurrent medical castration therapy with testosterone-suppressing therapy (e.g., gonadotropin releasing hormone agonist) required unless patient has had prior surgical castration
• Patients with soft tissue lesions thought to be due to prostate cancer identified below will not be eligible:
  • Hepatic lesions
  • Parenchymal lung lesions > 1 cm
  • Lymph node lesions > 3 cm
  • Other soft tissue lesions > 2 cm
• No brain metastasis
• No prior recombinant fowlpox-TRICOM vaccine or recombinant vaccinia-TRICOM vaccine; no prior samarium Sm 153 lexidronam pentasodium
• No prior splenectomy
• No systemic steroid or steroid eye drops within the past 2 weeks
• Recovered from prior therapy, including surgery
• ≥18 years of age
• ECOG 0–1
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• AST and ALT < 2.5 x upper limit of normal (ULN)
• Bilirubin < 1.5 mg/dL (≤ 3.0 mg/dL in patients with Gilbert’s syndrome)
• Creatinine normal OR creatinine clearance > 60 mL/min
• Proteinuria < 1+ OR urine protein < 1,000 mg/24 hours
• No other active malignancies within the past 12 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder)
• No life-threatening illnesses
• No HIV, hepatitis B, or hepatitis C positivity
• No autoimmune disease that requires or has required treatment
• No concurrent medical conditions that would preclude study participation

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Treatment Plan:

This is a randomized, open-label, pilot study.

• Patients will be randomized to 1 of the 2 treatment arms:
  
  
  Arm I:
  
  
  • Patients receive ¹⁵³Sm-EDTMP IV over one minute on Day 8
  • Treatment with ¹⁵³Sm-EDTMP will be repeated every 12 weeks in the absence of disease progression or unacceptable toxicity
  
  
  Arm II:
  
  
  • Patients receive PROSTAC-V/TRICOM subcutaneously (SC) on Day 1
  • Patients also receive ¹⁵³Sm-EDTMP as in Arm I
  • Patients receive PROSTVAC-F/TRICOM vaccine SC on Days 15 and 29
  • Patients receive sargramostim (GM-CSF) SC on Days 1–4, 15–18, and 29–32
  • Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
  
  
  
• Patients who are HLA-A2-positive undergo apheresis for immunological studies
• Blood serum is analyzed for interferon gamma-releasing T cells specific to prostate-specific antigen (PSA)-3A as measured by ELISPOT assay as well as antibodies to PSA, vaccinia, fowlpox, and antinuclear antibody titer
• Bone pain is assessed periodically
• After completion of study treatment, patients are followed periodically for up to 15 years

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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: 7/8/08
Updated: 3/14/07