Vaccine Therapy In Treating Patients With Cancer Of The Gastrointestinal Tract

Study Overview

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.

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.

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

CDR0000068497
UTMB-00-297
NCI-931

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-03-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-05-15
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-05-16
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Production of CAP 1-6D T cells
Production of cytotoxic T cells
Antitumor response
Frequency and severity of toxic effects

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed stage II, III, or IV adenocarcinoma of the gastrointestinal tract originating in 1 of the following:

Esophagus
Stomach
Pancreas
Small intestine
Colon or rectum
Gall bladder
Extrahepatic bile ducts
Ampulla of Vater
Completed standard therapy and at risk of recurrent disease OR has relatively stable metastatic disease and a life expectancy of at least 6 months
Carcinoembryonic antigen (CEA)-producing tumor as evidenced by detectable blood levels of CEA or positive for CEA on immunohistochemical staining
Human Leukocyte Antigen (HLA)-A2+

18 and over

Southwest Oncology Group (SWOG) 0-1

See Disease Characteristics

White Blood Count (WBC) at least 4,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8 g/dL

Serum Glutamic Oxalacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times upper limit of normal
Hepatitis B and C negative

Creatinine no greater than 2.0 mg/dL

No other prior malignancy unless currently disease free and off all therapy for that malignancy

Early skin cancer allowed
No AIDS
HIV negative
Not pregnant or nursing
Fertile patients must use effective contraception during and for 30 days after study participation

At least 4 weeks since prior immunotherapy

At least 4 weeks since prior chemotherapy

Not specified

At least 4 weeks since prior radiotherapy

At least 4 weeks since prior surgery

No other concurrent therapy for malignancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Robert P. Whitehead, MD, University of Texas

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record