Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UTMB-00-297 NCI-931, NCT00012246, 931

Objectives

1. 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.
2. Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients.
3. Determine whether this vaccine can produce antitumor responses in these patients.
4. Determine the frequency and severity of toxic effects associated with this vaccine in these patients.

Entry 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



• HLA-A2+

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-1

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 8 g/dL

Hepatic:

• SGOT or 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

Expected Enrollment

A total of 10-36 patients (5-18 per arm) will be accrued for this study within 36 months.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

University of Texas Medical Branch

Robert Whitehead, MD, Protocol chair(Contact information may not be current)		Ph: 409-772-2981

Registry Information
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
Trial Start Date		2002-07-22
Registered in ClinicalTrials.gov		NCT00012246
Date Submitted to PDQ		2001-01-16
Information Last Verified		2006-01-10

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