Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Phase 2TerminatedNCT00012246

The University of Texas Medical Branch, Galveston7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Colorectal Cancer Esophageal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior surgery Other: * No other concurrent therapy for malignancy

Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes