Trials / Terminated
TerminatedNCT00012246
Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- The University of Texas Medical Branch, Galveston · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Colorectal Cancer
- Esophageal Cancer
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- Gastric Cancer
- Pancreatic Cancer
- Small Intestine Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | carcinoembryonic antigen peptide 1-6D | |
| BIOLOGICAL | incomplete Freund's adjuvant | |
| BIOLOGICAL | sargramostim |
Timeline
- Start date
- 2002-07-01
- Primary completion
- 2006-07-01
- Completion
- 2006-07-01
- First posted
- 2003-01-27
- Last updated
- 2013-05-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00012246. Inclusion in this directory is not an endorsement.