Ignite Creation Date:
2024-05-05 @ 10:00 AM
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
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
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 |