Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Condition: Hormone Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ADENOVIRUS/PSA VACCINE
Intervention description: 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: prostate cancer; vaccine; immunotherapy

Summary:

      This investigational study involves treatment with an Ad/PSA vaccine for men with prostate
      cancer who present with evidence of hormone refractory metastatic disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men with prostate cancer who present with evidence of hormone refractory disease (D3).

          -  Men with a positive bone scan or a positive CT scan (with obvious soft tissue
             metastasis or lymph nodes >1 cm), a PSA doubling time of >/= 6 months, and a total PSA
             of <10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan
             with any PSA doubling time and asymptomatic.

          -  Scans must be obtained within 6 weeks of initiation of treatment.

          -  Written informed consent.

          -  Age >/= 18 years.

          -  Required laboratory values (obtained within 2 weeks of initiation of treatment)

          -  Serum creatinine </= 2.0 mg/dL

          -  Adequate hematologic function: granulocytes >/= 1800 per mm3, platelets >/= 100,000
             per mm3, WBC >/= 3700, and lymphocytes >590.

          -  Adequate hepatocellular function: AST <3x upper limit of normal and total bilirubin
             <1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).

          -  Castrate levels of testosterone of </= 50 ng/ml.

          -  PSA can be used as an eligibility criterion must be drawn within 28 days prior to
             injection number 1 and will be drawn on Day 1 for use as a baseline value.

        Exclusion criteria:

          -  Active or unresolved clinically significant infection.

          -  Parenteral antibiotics <7 days prior to initiation of treatment.

          -  Evidence of prior or current CNS metastases. Specific imaging is not necessary in the
             absence of signs or symptoms.

          -  Co-morbid medical conditions which would result in a life expectancy (participation)
             of less than 1 year.

          -  Patients with compromised immune systems; congenital, acquired, or drug-induced
             (immunosuppressive agents) will be excluded from the study. Use of prednisone at doses
             higher than 10 mg daily (or equipotent steroid doses) for more than 7 days within 3
             months of initiation of treatment is not allowed.

          -  Pre-existing malignancies that required treatment within the past 5 years except for
             basal or squamous cell cancers of the skin.

          -  Prior participation in any vaccine studies for non-infectious diseases.

          -  Prior chemotherapy, defined as prior cytotoxic chemotherapy for prostate cancer (or
             any cancer unless more than 5 years have elapsed). Examples of cytotoxic chemotherapy
             are mitoxantrone/prednisone and taxanes. Drugs such as Casodex or ketoconazole
             treatment must have been completed at least 6 weeks prior to initiation of treatment.

          -  The inability to understand the language and the clinical protocol.

          -  Allergy or religious objection to pork products; Gelfoam is produced from pork.