Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Terminated

CT.gov ID

NCT00012246

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Primary Purpose:

Treatment

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 :

Jul 1, 2002

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Production of CAP 1-6D T cells []
Production of cytotoxic T cells []
Antitumor response []
Frequency and severity of toxic effects []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

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+

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Southwest Oncology Group (SWOG) 0-1

Life expectancy:

See Disease Characteristics

Hematopoietic:

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

Hepatic:

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

Renal:

Creatinine no greater than 2.0 mg/dL

Other:

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