Expired Study
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Galveston, Texas 77555


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00012246


Primary Contact:

Study Chair
Robert P. Whitehead, MD
University of Texas


Backup Contact:

N/A


Location Contact:

Galveston, Texas 77555
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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