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Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

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 ID: NCT00012246

Study Description

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Texas Medical Branch, Galveston, Texas, United States

Contact Details

Name: Robert P. Whitehead, MD

Affiliation: University of Texas

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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