Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02140996
Status:
UNKNOWN
Last Update Posted:
2016-10-14
First Post:
2014-05-08
Brief Title:
Safety Study of Human MUC-1 Mucin-1 Adenoviral Vector Vaccine for Immunotherapy of Epithelial Cancers
Sponsor:
Singapore Clinical Research Institute
Organization:
Singapore Clinical Research Institute
Study Overview
Official Title:
Ad-sig-hMUC-1ecdCD40L Vector Vaccine for Immunotherapy of Epithelial Cancers
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
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:
MUC-1
Brief Summary:
In epithelial cancer MUC-1mucin-1 overexpression is thought to disrupt E-cadherin function leading to anchorage-independent tumor cell growth and metastases Elevated levels of MUC-1 expression have been found in patients with epithelial cancers of breast ovarian colon and lung Furthermore overexpression of MUC-1 is independently correlated with adverse clinical phenotypes metastases and resistance to chemotherapy In animal models suppressing the expression of MUC-1 reduces the rates of growth and metastasis and increases the sensitivity of the cancer to chemotherapy-induced cell death
In this study an adenoviral Ad-sig-hMUC-1ecdCD40L vector encoding a fusion protein in which the hMUC-1 epithelial antigen is attached to the CD40L CD40 ligand The preclinical results have also shown that two subcutaneous Ad-sig-hMUC-1ecdCD40L vector injections can induce immunity through activation of dendritic cells and promotion of antigen specific B cells or antigen specific CD8 effector T cells which suppresses the growth of hMUC-1 tumor cells in 100 of the vaccinated mice without Interleukin IL 2 stimulation being required this suggests that the Ad-sig-hMUC-1ecdCD40L vector prime-hMUC-1ecdCD40L protein boost has the potential to be an effective vaccine in epithelial tumors Therefore the safety and tolerability of the Ad-sig-hMUC-1ecdCD40L vector vaccine will be tested in this phase I non-randomized open label dose escalation trial for men or women with metastatic or recurrent epithelial cancers of the lung breast ovary prostate and colon
In this study an adenoviral Ad-sig-hMUC-1ecdCD40L vector encoding a fusion protein in which the hMUC-1 epithelial antigen is attached to the CD40L CD40 ligand The preclinical results have also shown that two subcutaneous Ad-sig-hMUC-1ecdCD40L vector injections can induce immunity through activation of dendritic cells and promotion of antigen specific B cells or antigen specific CD8 effector T cells which suppresses the growth of hMUC-1 tumor cells in 100 of the vaccinated mice without Interleukin IL 2 stimulation being required this suggests that the Ad-sig-hMUC-1ecdCD40L vector prime-hMUC-1ecdCD40L protein boost has the potential to be an effective vaccine in epithelial tumors Therefore the safety and tolerability of the Ad-sig-hMUC-1ecdCD40L vector vaccine will be tested in this phase I non-randomized open label dose escalation trial for men or women with metastatic or recurrent epithelial cancers of the lung breast ovary prostate and colon
Detailed Description:
None
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