Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257738
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2005-11-21
Brief Title:
0804 GCC MAGE-A3HPV 16 Vaccine for Squamous Cell Carcinoma of the Head and Neck
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 1 Open Label Dose Escalation Study to Evaluate the Effect of Four Doses of MAGE-A3HPV 16 Trojan Peptides 0001 and 0002 Administered Subcutaneously in Combination With Montanide and GM-CSF on Immunological Response Safety Tolerability and Preliminary Efficacy in Patients With Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Squamous Cell Carcinoma of the Head and Neck SCCHN is a devastating illness the treatment of which is associated with significant morbidity This type of cancer affects 43000 individuals each year with an estimated survival rate of 50 A potential treatment alternative for this patient population is the use of peptide-based immunotherapy This clinical tial will be using a vaccines comprised on the Trojan peptides MAGE-A3 and HPV 16 to treat patients with Squamous Cell Carcinoma of the Head and Neck who have recurrent progressive or metastatic SCCHN
Detailed Description:
Squamous Cell Carcinoma of the Head and Neck affects 43000 individuals in the United States annually with an estimated overall survival rate of 50 In order to improve both the survival rate and quality of life for patients who develop unresectable disease recurrence new therapeutic alternatives are mandated One potential treatment alternative for this patient population is the use of peptide-based immunotherapy Despite the success fo preclinical studies using peptide vaccines therapeutic responses in patients have been sporadic The reasons for failure are multifactorial and include problems with patient selection a limited number of antigenic targets and an inability to correlate immunologic response with therapeutic efficacy Specifically patients with disseminated SCCHN have defects in antigen processing presentation and effector mechanisms that limit their ability to respond to T cell based immunotherapy Additionally a paucity of antigenic peptide epitopes are defined for SCCHN and immunologic monitoring does not correlate well with clinical response
Recently several investigators including our research team have identified a high prevalence of MAGE-A3 and HPV 16 on SCCHN and characterized several putative cytolytic and helper epitopes Additionally we have defined a novel method to enhance the immune response to therapeutic peptide vaccines using Trojan complexes composed of CD4 and CD8 T-cell epitopes connected by furin cleavable linkers
In order to define the feasibility and safety of these agents in combination with GM-CSF and montanide ISA 51 for the immunotherapy of SCCHN in this proposed trial we will screen patients for immunologic competence based on specific eligibility criteria including both antigen and HLA-A2 expression on tumors In registered patients we will test the ability of two novel Trojan peptide complexes composed of MAGE-A3 and human papilloma virus 16 HPV 16 epitopes to stimulate antigen-specific CD 4 and CD 8 T-cell responses Finally we will correlate immunologic response with cell dose and the generation of both HPV 16 and MAGE-A3 antigen loss and HLA-A2 loss variants on tumors by evaluating patients for 1 Changes in tumor size by both physical measurement and CT plus PET measurement 2 Determining what proportions of individuals who achieve a complete response CR partial response PR or have stable disease SD 3 Progression-free survival 4 Survival Successful completion of this clinical trial will result in the development of a strong foundation for a Phase IIIII clinical trial using HPV 16 and MAGE-A3 Trojan peptides for the immunotherapy of SCCHN
Recently several investigators including our research team have identified a high prevalence of MAGE-A3 and HPV 16 on SCCHN and characterized several putative cytolytic and helper epitopes Additionally we have defined a novel method to enhance the immune response to therapeutic peptide vaccines using Trojan complexes composed of CD4 and CD8 T-cell epitopes connected by furin cleavable linkers
In order to define the feasibility and safety of these agents in combination with GM-CSF and montanide ISA 51 for the immunotherapy of SCCHN in this proposed trial we will screen patients for immunologic competence based on specific eligibility criteria including both antigen and HLA-A2 expression on tumors In registered patients we will test the ability of two novel Trojan peptide complexes composed of MAGE-A3 and human papilloma virus 16 HPV 16 epitopes to stimulate antigen-specific CD 4 and CD 8 T-cell responses Finally we will correlate immunologic response with cell dose and the generation of both HPV 16 and MAGE-A3 antigen loss and HLA-A2 loss variants on tumors by evaluating patients for 1 Changes in tumor size by both physical measurement and CT plus PET measurement 2 Determining what proportions of individuals who achieve a complete response CR partial response PR or have stable disease SD 3 Progression-free survival 4 Survival Successful completion of this clinical trial will result in the development of a strong foundation for a Phase IIIII clinical trial using HPV 16 and MAGE-A3 Trojan peptides for the immunotherapy of SCCHN
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 |
|---|---|---|---|
| R01DE015324 | NIH | None | httpsreporternihgovquickSearchR01DE015324 |