A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

Completed · Phase 2

Conditions studied: Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer

In brief

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.

Key facts

Study ID

NCT00108732

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2006-02-01

Expected to finish

2010-10-01

Last updated by the study team

2015-06-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesical involvement, provided all visible disease was surgically removed) that have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy, as defined below; patients with lymph node involvement (D1) are not eligible
• Histologically confirmed diagnosis of prostate cancer
• Previous treatment with definitive surgery or radiation therapy or both
• No evidence of metastatic disease on physical exam, CT (MRI), and bone scan within 4 weeks prior to randomization
• Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used >= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
• No therapy modulating testosterone levels (such as leuteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, and herbal products are not permitted at any time during the period that the PSA values are being collected
• Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL at the time of enrollment within 4 weeks prior to randomization
• There must be one PSA measurement (referred to as the baseline PSA) obtained within one week prior to registration; the baseline PSA value must be greater than 0.4 ng/mL (after prostatectomy) or greater than 1.5 ng/mL (after radiation therapy)
• All patients must have evidence of biochemical progression as determined by 3 PSA measurements (PSA1, PSA2, PSA3), each higher than the previous value, each obtained at least 4 weeks apart from the others with the most recent one (PSA3) being the baseline PSA; all of these PSA values must be obtained at the same reference lab; the earliest (PSA1) must be done within 6 months prior to registration.
• PSA doubling time (PSADT) must be less than 12 months, calculated using the following formula:
• PSADT in days = (0.693 (t))/(In (PSA3) - In (PSA2)) Where t = the number of days between PSA3 and PSA2 In = the natural log PSADT in months = PSADT in days divided by 30.4375
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
• Leukocytes >= 3000/mm\^³
• Granulocytes >= 1500/mm\^3
• Platelet count >= 100,000/mm\^3
• Serum creatinine within normal institutional limits or creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal (a calculated clearance may be used); an initial urine analysis will be required with grade 0 proteinuria and no abnormal sediment; for any positive protein a 24 hour urine should be less than 1,000 mg per 24 hours and no indication of chronic renal disease
• Serum total bilirubin, and alkaline phosphatase within normal institutional limits
• SGOT (AST) and SGPT (ALT) =< 2.5 x institutional upper limit of normal
• Patients cannot have evidence of immunosuppression:
• Patients must be human immunodeficiency virus sero-negative due to the potential for severe reactions to vaccinia and the need for an intact immune system to respond to the immunization
• Patients must not have active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has required systemic immunosuppressive therapy or has impaired organ function including CNS, heart, lungs, kidneys, skin, and GI tract are ineligible; patients receiving replacement thyroid hormone would be eligible
• No concurrent use of systemic steroids, except for local (topical, nasal, or inhaled) steroid use; steroid eye drops are contraindicated for at least 2 weeks before vaccinia vaccination and at least 4 weeks post vaccinia vaccination
• Patients must be hepatitis B and hepatitis C negative
• Patients must have a normal PT/INR within 4 weeks prior to randomization
• Patients must not be receiving any other investigational agents or receiving concurrent anticancer therapy

Where it is running

• Baptist Cancer Institute — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Eastern Cooperative Oncology Group — Boston, Massachusetts, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• New York University Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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