Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
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.
Extrahepatic Bile Duct Cancer
Small Intestine Cancer
Biological: carcinoembryonic antigen peptide 1-6D
Biological: incomplete Freund's adjuvant
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Production of CAP 1-6D T cells [ Designated as safety issue: No ]
- Production of cytotoxic T cells [ Designated as safety issue: Yes ]
- Antitumor response [ Designated as safety issue: No ]
- Frequency and severity of toxic effects [ Designated as safety issue: Yes ]
|Study Start Date:||July 2002|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012246
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0209|
|Study Chair:||Robert P. Whitehead, MD||University of Texas|