Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Official Title: A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

Study ID: NCT00004029

Conditions

Prostate Cancer

Interventions

recombinant viral vaccine therapy

sargramostim

Study Description

Brief Summary: Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.

Detailed Description: OBJECTIVES: I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate. II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity. III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity. IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone. OUTLINE: This is an open label, dose escalation study. Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF. Patients are followed monthly for 6 months.