NCT00005039

Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)

A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate. II. Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients. III. Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients. IV. Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order. OUTLINE: This is a randomized, open-label, multicenter, dose-escalation study of recombinant fowlpox prostate-specific antigen (PSA) vaccine. SAFETY COHORT: The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly (IM). Treatment repeats every 4 weeks for 3 courses. In the absence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level. In the presence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at a dose level lower than the first cohort dose level. The maximum tolerated dose (MTD) is the dose preceding that at which 1 of 6 patients experiences grade 3 or worse dose-limiting toxicity. Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine: GROUP A (no prior recombinant vaccinia-PSA vaccine): Patients are randomized to one of two vaccination arms: ARM I: Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses. ARM II: Patients receive the same vaccines as in arm I but in reverse order. GROUP B (prior recombinant vaccinia-PSA vaccine): Patients receive treatment as in arm I, group A. GROUPS A AND B: Patients with stable or responding disease at 6 months after completion of vaccination therapy may continue treatment on the group and arm to which they were originally assigned. Treatment repeats every 6-9 months in the absence of disease progression. Patients are followed monthly for 6 months and then every 3 months thereafter.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	recombinant fowlpox-prostate specific antigen vaccine	Given IM
BIOLOGICAL	recombinant vaccinia prostate-specific antigen vaccine	Given intradermally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-01-01
• Primary completion: 2007-03-01
• First posted: 2003-01-27
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States