Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110526
Status:
WITHDRAWN
Last Update Posted:
2013-10-24
First Post:
2005-05-10
Brief Title:
Gene Therapy for Prostate Cancer That Returns After Radiation Therapy
Sponsor:
Simon Hall
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants met eligibility requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test a new treatment for prostate cancer We have been exploring the use of cytokine immune stimulating gene therapy by directly injecting a virus which produces a cytokine called interleukin-12 IL-12 into the prostate gland to control tumor growth We propose to explore the use of adenovirus-mediated human interleukin-12 AdhIL-12 in patients with recurrent non-metastatic prostate cancer following radiation therapy in a Phase I trial Participants will be placed in rising dose groups with the primary endpoint of learning the maximum dose that can safely be given by injection directly into the prostate gland Toxicity will be determined through physical examination laboratory values and blood levels of cytokines Evidence of an immune response against prostate proteins will also be monitored If the treatment works the cancer will shrink or not grow This will be monitored by prostate specific antigen PSA levels in the blood However we do not know if this treatment will be effective If the PSA continues to rise after treatment participants will be taken off study and offered other treatment There is no compensation for participation in this research study There will be no charge for the treatment with gene therapy or the monitoring associated with this research study Monitoring will occur in a specially designated clinical research center
Detailed Description:
Patients with radiorecurrent prostate cancer have few viable treatment options both in terms of efficacy and morbidity Local therapies fail even in highly selected patients due to locally advanced disease microscopic metastases and a worsening of the biology of cancer cells Furthermore attempts at salvage local treatments have the complications of incontinence impotence and in some cases unremitting penile pain Pre-clinical studies in a mouse model of prostate cancer have noted the potential benefit of adenovirus-mediated gene therapy to deliver IL-12 in this clinical scenario This treatment was able to significantly growth suppress the injected tumor to prolong survival and reduce the number of pre-established metastases The mechanisms underlying this activity involved both innate immunity neutrophils and natural killer NK cells and acquired immunity T cells and enhanced expression of Fas to further sensitize FasFas ligand FasL killing
This is a Phase I study Therefore the primary objective is finding the Maximum Tolerated Dose Within this realm will be monitoring of pro-inflammatory cytokines Secondary aspects will involve correlating important mechanisms identified in the pre-clinical model induction of T cells
This is a Phase I study Therefore the primary objective is finding the Maximum Tolerated Dose Within this realm will be monitoring of pro-inflammatory cytokines Secondary aspects will involve correlating important mechanisms identified in the pre-clinical model induction of T cells
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 |
|---|---|---|---|
| A-11425 | None | None | None |