Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00012246|
Recruitment Status : Terminated (Administratively Terminated)
First Posted : January 27, 2003
Last Update Posted : May 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Esophageal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer||Biological: carcinoembryonic antigen peptide 1-6D Biological: incomplete Freund's adjuvant Biological: sargramostim||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|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|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- Production of CAP 1-6D T cells
- Production of cytotoxic T cells
- Antitumor response
- Frequency and severity of toxic effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012246
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0209|
|Study Chair:||Robert P. Whitehead, MD||University of Texas|