Viewing Study NCT00002637



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002637
Status: COMPLETED
Last Update Posted: 2013-06-25
First Post: 1999-11-01

Brief Title: Biological Therapy in Treating Patients With Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Organization: Memorial Sloan Kettering Cancer Center

Study Overview

Official Title: PHASE III STUDY OF IMMUNIZATION WITH MHC CLASS I MATCHED ALLOGENEIC HUMAN PROSTATIC CARCINOMA CELLS ENGINEERED TO SECRETE INTERLEUKIN-2 AND INTERFERON-GAMMA
Status: COMPLETED
Status Verified Date: 2013-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Interleukin-2 may stimulate a persons 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 III trial to study the effectiveness of biological therapy using interleukin-2 and interferon gamma in treating patients with advanced prostate cancer
Detailed Description: 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 ng24 hrmillion cells of interleukin-2 IL-2 and approximately 072 U24 hrmillion 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-V95-0629 Registry Identifier PDQ Physician Data Query None
CDR0000064100 REGISTRY None None