Biological Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00002637|
Recruitment Status : Completed
First Posted : June 10, 2004
Last Update Posted : June 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: aldesleukin Biological: gene-modified tumor cell vaccine therapy Biological: recombinant interferon gamma||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||PHASE I/II STUDY OF IMMUNIZATION WITH MHC CLASS I MATCHED ALLOGENEIC HUMAN PROSTATIC CARCINOMA CELLS ENGINEERED TO SECRETE INTERLEUKIN-2 AND INTERFERON-GAMMA|
|Study Start Date :||January 1995|
|Actual Primary Completion Date :||February 2001|
|Actual Study Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002637
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Susan Slovin, MD, PhD||Memorial Sloan Kettering Cancer Center|