Expired Study
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Bethesda, Maryland 20892


RATIONALE: Vaccines made from a gene-modified virus may make the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in patients with progressive or locally recurrent prostate cancer.

Study summary:

OBJECTIVES: Primary - 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. Secondary - Determine changes in prostate-specific antigen-specific T-cell response in HLA-A2-positive patients treated with this regimen. OUTLINE: 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. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 30 months.


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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Lymphocyte count ≥ 500/mm^3 - Hemoglobin ≥ 10 g/dL Hepatic - 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 Renal - 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 Cardiovascular - No New York Heart Association class II-IV heart disease - No objective evidence of congestive heart failure by physical exam or imaging Pulmonary - No pulmonary disease that causes fatigue or dyspnea during ordinary physical activity Neurologic - No history of seizures - No history of encephalitis - No history of multiple sclerosis Gastrointestinal - No inflammatory bowel disease - No Crohn's disease - No ulcerative colitis - No active diverticulitis Immunologic - 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 Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - No prior vaccinia unless immune to vaccinia - No other concurrent immunotherapy Chemotherapy - 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 Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior surgery - No prior splenectomy - No concurrent major surgery Other - Recovered from all prior therapy



Primary Contact:

Principal Investigator
James L. Gulley, MD, PhD, FACP
National Cancer Institute (NCI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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