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| Sponsors and Collaborators: |
University of Texas National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012246 |
Purpose
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 | Intervention | Phase |
|
Colorectal Cancer Esophageal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer |
Drug: carcinoembryonic antigen peptide 1-6D Drug: incomplete Freund's adjuvant Drug: sargramostim |
Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer Esophageal Cancer Esophagus Disorders Intestinal Cancer Pancreatic Cancer Stomach Cancer |
| ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor Freund's adjuvant Montanide ISA 51 Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage II, III, or IV adenocarcinoma of the gastrointestinal tract originating in 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other prior malignancy unless currently disease free and off all therapy for that malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |||||
| University of Texas Medical Branch | |||||
| Galveston, Texas, United States, 77555-0209 | |||||
| University of Texas |
| National Cancer Institute (NCI) |
| Study Chair: | Robert P. Whitehead, MD | University of Texas |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068497, UTMB-00-297, NCI-931 |
| First Received: | March 3, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012246 |
| Health Authority: | United States: Federal Government |
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