Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012246
Status:
TERMINATED
Last Update Posted:
2013-05-16
First Post:
2001-03-03
Brief Title:
Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
A Trial Of Vaccination With The Carcinoembryonic Antigen CEA Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor GM-CSF In HLA-A2 Patients With CEA Producing Adenocarcinomas Of Gastrointestinal GI Tract Origin
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract
PURPOSE Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract
Detailed Description:
OBJECTIVES
Determine whether immunization with carcinoembryonic antigen CEA peptide 1-6D CAP 1-6D emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim GM-CSF can generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of gastrointestinal tract origin
Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients
Determine whether this vaccine can produce antitumor responses in these patients
Determine the frequency and severity of toxic effects associated with this vaccine in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carcinoembryonic antigen peptide 1-6D CAP 1-6D emulsified in Montanide ISA-51 adjuvant subcutaneously on day 1
Arm II Patients receive CAP 1-6D dissolved in sargramostim GM-CSF intradermally on day 1
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then as necessary
PROJECTED ACCRUAL A total of 10-36 patients 5-18 per arm will be accrued for this study within 36 months
Determine whether immunization with carcinoembryonic antigen CEA peptide 1-6D CAP 1-6D emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim GM-CSF can generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of gastrointestinal tract origin
Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients
Determine whether this vaccine can produce antitumor responses in these patients
Determine the frequency and severity of toxic effects associated with this vaccine in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carcinoembryonic antigen peptide 1-6D CAP 1-6D emulsified in Montanide ISA-51 adjuvant subcutaneously on day 1
Arm II Patients receive CAP 1-6D dissolved in sargramostim GM-CSF intradermally on day 1
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then as necessary
PROJECTED ACCRUAL A total of 10-36 patients 5-18 per arm will be accrued for this study within 36 months
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-931 | None | None | None |
| UTMB-00-297 | None | None | None |