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.
- 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
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
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.
- Histologically confirmed stage II, III, or IV adenocarcinoma of the gastrointestinal
tract originating in 1 of the following:
- 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
- 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
PRIOR CONCURRENT THERAPY:
- 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