Sequential Vaccinations in Prostate Cancer Patients
Status:
Completed
Trial end date:
2009-06-08
Target enrollment:
Participant gender:
Summary
Background:
" Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and
follows lung cancer as the leading cause of cancer death.
" Vaccine strategies represent a novel therapeutic approach in the treatment for prostate
cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen
(PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial
cells.
Objectives:
" The primary objective is to determine the impact of granulocyte-macrophage colony
stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating
factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.
" Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in
patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay
analysis.
" To document any objective anti-tumor responses that may occur.
Eligibility:
" Patients must have androgen insensitive metastatic prostate cancer.
" All patients will have received and progressed on hormonal therapy.
" Must have objective evidence of metastasis or relapsing local disease. Therefore, must have
a rising PSA and at least one of the following: positive bone scan, palpable disease, or
positive imaging studies.
" Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group
(ECOG) status of 0 to 2.
"Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+).
" Granulocyte count greater than or equal to 1,500/mm^3, Platelet greater than or equal to
100,000/mm^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater
than or equal to 500/mm^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine
Clearance greater than or equal to 60
" No significant cardiac disease, no significant pulmonary disease, no serious inter-current
medical illness.
Design:
" Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as
well as two doses of rFGM-CSF respectively.
"This study will be conducted as a small, randomized pilot study to compare the immunologic
effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony
stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF.
"This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.
The maximum accrual to the trial should be 62.