Clinical Trial Details

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Study ID NCI-2012-02319
Investigator
Joseph Paul Eder,   Dana-Farber Cancer Institute
Title Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions Biological: recombinant fowlpox-prostate specific antigen vaccine
Biological: recombinant vaccinia prostate-specific antigen vaccine
Other: laboratory biomarker analysis
Phase Phase 2
Purpose Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following: - Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL - Bone scan positive and PSA at least 10 ng/mL - Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL - Prior radiotherapy and PSA at least 10 ng/mL - Prior cryosurgery and PSA at least 10 ng/mL - PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079
  • No symptomatic metastatic disease (no bony pain)
  • Complete HLA typing required
  • Performance status - ECOG 0 or 1
  • WBC greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Bilirubin less than 2.0 mg/dL
  • SGPT less than 4 times upper limit of normal
  • Creatinine less than 4.0 mg/dL
  • No altered immune function such as eczema
  • No autoimmune diseases such as the following: - Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia - Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma - Myasthenia gravis - Goodpasture's syndrome - Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
  • HIV negative
  • No allergy or untoward reaction to prior vaccinia (smallpox) vaccination
  • No hypersensitivity to eggs
  • No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster)
  • No other concurrent serious illness
  • No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days
  • Fertile patients must use effective contraception
  • No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination: - Children under age 5 - Pregnant or nursing women - Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders - Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) - Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection
  • See Disease Characteristics
  • See Endocrine therapy
  • Prior vaccinia (smallpox) immunization required
  • No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer
  • No prior chemotherapy for metastatic disease
  • No concurrent anticancer chemotherapy
  • No prior hormonal therapy for metastatic disease
  • Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed
  • Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B)
  • No concurrent hormonal therapy or steroids
  • See Disease Characteristics
  • See Endocrine therapy
  • No concurrent radiotherapy
  • See Disease Characteristics
  • See Endocrine therapy
  • No prior splenectomy
  • At least 3 days since prior antibiotics
  • No concurrent immunosuppressive treatment (e.g., after organ transplantation)
  • Study Location
    Dana-Farber Cancer Institute
    Boston, Massachusetts, 02115
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/21/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00005039


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