A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease
- Compare the difference in time to radiographic evidence of disease progression at 6
months in patients with hormone-refractory prostate cancer when treated with vaccine
containing recombinant vaccinia-prostate-specific antigen (PSA) admixed with rV-B7.1
plus recombinant fowlpox-PSA vaccine, sargramostim (GM-CSF), and interleukin-2 vs
- Evaluate the vaccination therapy in relation to the change in T-cell precursor
frequency and to the rise of serum PSA in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to HLA-A2 typing
(positive vs negative). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive vaccine containing recombinant vaccinia-prostate-specific
antigen (PSA) and rV-B7.1 subcutaneously (SC) on day 2 only. Beginning on day 30,
patients receive recombinant fowlpox-PSA vaccine SC every 4 weeks for 12 vaccinations
and then every 12 weeks thereafter. Patients also receive sargramostim (GM-CSF) SC
daily on days 1-4 and interleukin-2 SC daily on days 8-12 with each vaccination.
Patients without disease progression after 12 courses receive the vaccine regimen every 12
- Arm II: Patients receive oral nilutamide daily. Treatment continues in both arms for at
least 6 months in the absence of disease progression or unacceptable toxicity.
After 6 months of therapy, patients with a rising PSA and no radiographic evidence of
disease progression may receive therapy in the other arm in addition to the therapy to which
they were randomized.
Patients are followed monthly for 6 months and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 56-78 patients (28-39 per treatment arm) will be accrued for
this study within 1.5-2 years.
Allocation: Randomized, Primary Purpose: Treatment
Philip M. Arlen, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|