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PHASE I/II STUDY OF IMMUNIZATION WITH MHC CLASS I MATCHED ALLOGENEIC HUMAN PROSTATIC CARCINOMA CELLS ENGINEERED TO SECRETE INTERLEUKIN-2 AND INTERFERON-GAMMA
RATIONALE: Interleukin-2 may stimulate a person's white blood cells including natural killer cells to kill prostate cancer cells. Interferon gamma may interfere with the growth of the cancer cells. Combining interferon gamma with interleukin-2 may be a more effective treatment for prostate cancer. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy using interleukin-2 and interferon gamma in treating patients with advanced prostate cancer.
OBJECTIVES: I. Evaluate the safety of immunization with HLA class I-matched allogeneic human prostate carcinoma cells genetically engineered to secrete interleukin-2 and interferon gamma in patients with prostate carcinoma. II. Evaluate the antitumor effects of this treatment as assessed by post-therapy declines in PSA. III. Evaluate the induction of cellular and humoral immunity in vivo with this treatment. OUTLINE: Tumor Cell Vaccine Therapy. Immunization with irradiated, MHC class I-matched allogeneic human prostate carcinoma cells, LNCaP cells, engineered to secrete approximately 58 ng/24 hr/million cells of interleukin-2 (IL-2) and approximately 0.72 U/24 hr/million cells of interferon gamma (IFN-G). PROJECTED ACCRUAL: Up to 12 patients will be entered on the Phase I study; accrual will continue to a total of 25 patients treated at the MTD (Phase II). Accrual is expected to require 2 years.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
January 1, 1995
Primary Completion Date
February 1, 2001
Completion Date
February 1, 2001
Last Updated
June 25, 2013
25
ESTIMATED participants
aldesleukin
BIOLOGICAL
gene-modified tumor cell vaccine therapy
BIOLOGICAL
recombinant interferon gamma
BIOLOGICAL
Lead Sponsor
Memorial Sloan Kettering Cancer Center
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT04550494