Phase I Pilot Study of Vaccine Therapy Comprising Priming Vaccinations of Vaccinia-PSA-TRICOM and Recombinant Fowlpox GM-CSF (rF-GM-CSF) Followed By Boosting Vaccinations of Fowlpox-PSA-TRICOM With or Without rF-GM-CSF in Patients With Progressive or Locally Recurrent Prostate Cancer

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Alternate Title

Vaccine Therapy in Treating Patients With Progressive or Locally Recurrent Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentCompleted18 and overNCINCI-05-C-0017
NCI-6066, 6066, NCT00098449

Special Category: NCI Web site featured trial



  1. Determine the clinical safety and feasibility of vaccine therapy comprising priming vaccinations of vaccinia-PSA-TRICOM and recombinant fowlpox-GM-CSF (rF-GM-CSF) followed by boosting vaccinations of fowlpox-PSA-TRICOM with or without rF-GM-CSF in patients with progressive or locally recurrent prostate cancer.


  1. Determine changes in prostate-specific antigen-specific T-cell response in HLA-A2-positive patients treated with this regimen.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed* adenocarcinoma of the prostate, meeting 1 of the following criteria:
    • Locally recurrent disease after prior local radiotherapy or cryotherapy, defined as 3 consecutive rising prostate-specific antigen levels AND confirmed by biopsy performed ≥ 18 months after completion of radiotherapy
    • Not a candidate for or refused local definitive therapy (surgery or radiation therapy) AND had clinically progressive disease during androgen deprivation therapy, defined as 3 increases in PSA over nadir, separated by ≥ 1 week

     [Note: *Patients without a pathological specimen available are eligible provided there is histologic diagnosis of prostate cancer and a clinical course consistent with prostate disease]

  • Minimal extraprostatic disease allowed
  • No clinically active brain metastases

Prior/Concurrent Therapy:

    Biologic therapy

  • No prior vaccinia unless immune to vaccinia
  • No other concurrent immunotherapy


  • No concurrent anticancer chemotherapy

    Endocrine therapy

  • See Disease Characteristics
  • No steroid eye drops for at least 2 weeks before, during, and for at least 4 weeks after study treatment
  • Concurrent hormonal therapy allowed
  • No concurrent systemic steroids, including glucocorticoids, except for physiologic doses for systemic steroid replacement or local (i.e., topical, nasal, or inhaled) steroid use


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior surgery
  • No prior splenectomy
  • No concurrent major surgery


  • Recovered from all prior therapy

Patient Characteristics:


  • 18 and over

    Performance status

  • ECOG 0-2

    Life expectancy

  • At least 6 months


  • Granulocyte count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Lymphocyte count ≥ 500/mm3
  • Hemoglobin ≥ 10 g/dL


  • Bilirubin < 1.5 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST and ALT < 2.5 times upper limit of normal
  • Hepatitis B and C negative


  • Creatinine < 2.0 mg/dL OR creatinine clearance > 60 mL/min
  • No proteinuria, defined as ≥ 1,000 mg of protein on 24-hour urine collection
  • No abnormal urine sediment or hematuria unless the underlying cause is determined to be non-renal


  • No New York Heart Association class II-IV heart disease
  • No objective evidence of congestive heart failure by physical exam or imaging


  • No pulmonary disease that causes fatigue or dyspnea during ordinary physical activity


  • No history of seizures
  • No history of encephalitis
  • No history of multiple sclerosis


  • No inflammatory bowel disease
  • No Crohn's disease
  • No ulcerative colitis
  • No active diverticulitis


  • HIV negative
  • History of autoimmunity not requiring systemic immunosuppressive therapy and not threatening vital organ function (e.g., CNS, heart, lungs, kidneys, skin, or gastrointestinal tract) allowed
  • No active autoimmune disease, including any of the following:
    • Addison's disease
    • Hashimoto's thyroiditis
    • Systemic lupus erythematosus
    • Sjögren's syndrome
    • Scleroderma
    • Myasthenia gravis
    • Goodpasture's syndrome
    • Graves' disease
  • No other altered immune function, including any of the following conditions:
    • History of or active eczema or other eczematoid skin disorders
    • Atopic dermatitis
    • Other skin diseases
    • Open wounds
  • No history of allergy or untoward reaction to prior vaccination with vaccinia virus or any component of study treatment
  • No serious hypersensitivity to egg products


  • Fertile patients must use effective contraception during and for at least 4 months after study treatment
  • Able to avoid close household contact with any of the following for at least 3 weeks after each study vaccination:
    • Individuals with a history of or active eczema or other eczematoid skin disorders
    • Individuals with acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until the condition resolves
    • Pregnant or nursing women
    • Children age 3 and under
    • Immunodeficient or immunosuppressed (by disease or therapy) individuals, including HIV-positive individuals
  • No other malignancy within the past year except nonmelanoma skin cancer or carcinoma in situ of the bladder
  • No other life-threatening illness
  • No other serious medical illness that would preclude study participation

Expected Enrollment


A total of 3-30 patients will be accrued for this study within 30 months.


Primary Outcome(s)

Safety by CTCAE v 3.0 continuously

Secondary Outcome(s)

Compare immunologic response by ELISPOT at baseline and at day 113
Prostate-specific antigen (PSA) changes by monthly serum PSA


This is a dose-escalation study of booster vaccinations comprising vaccinia-PSA-TRICOM (rV-PSA-TRICOM) with or without recombinant fowlpox-GM-CSF (rF-GM-CSF). Patients are assigned to 1 of 5 groups.

  • Groups 1 and 2: Patients receive priming vaccinations comprising rV-PSA-TRICOM subcutaneously (SC) and rF-GM-CSF SC on day 1. Patients also receive a booster vaccination comprising fowlpox-PSA-TRICOM (rF-PSA-TRICOM) by intraprostatic (IP) injection on days 29, 57, and 85.
  • Groups 3 and 4: Patients receive priming and booster vaccinations as in groups 1 and 2. Patients also receive a booster vaccination comprising rF-GM-CSF IP on days 29, 57, and 85.
  • Group 5: Patients receive priming and booster vaccinations as in groups 3 and 4. Patients also receive booster vaccinations comprising rF-PSA-TRICOM SC and rF-GM-CSF SC on days 29, 57, and 85.

Cohorts of 3-6 patients in each group receive escalating doses of booster vaccinations comprising rF-PSA-TRICOM with or without rF-GM-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Treatment in all groups continues in the absence of unacceptable toxicity or disease progression.

Patients are followed annually for up to 15 years.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

James Gulley, MD, PhD, FACP, Principal investigator
Ph: 301-496-4343

Related Information

Featured trial article
Web site for additional information

Registry Information

Official TitleA Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer and Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy
Trial Start Date2004-11-15
Trial Completion Date2010-06-10
Registered in ClinicalTrials.govNCT00098449
Date Submitted to PDQ2004-10-20
Information Last Verified2008-04-04

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.