Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
Summary
RATIONALE: Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer).
Description
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate.
- Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients.
- Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients.
- 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.
PROJECTED ACCRUAL: Approximately 6-86 patients (6 in the safety cohort, 15-20 per arm in group A, and approximately 10 in group B) will be accrued for this study within 1 year.
Study Design
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
recombinant fowlpox-prostate apecific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine
Location
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston
Massachusetts
United States
02115
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00005039
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Smallpox Vaccine
A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)
Prostatic Secretory Proteins
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
Molecular Farming
The large scale production of pharmaceutically important and commercially valuable RECOMBINANT PROTEINS.
Vaccinia Virus
The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.
Prostate-specific Antigen
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
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