Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 :	July 2002
Actual Primary Completion Date :	July 2006
Actual Study Completion Date :	July 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

National Cancer Institute (NCI)

Investigators

Study Chair:	Robert P. Whitehead, MD	University of Texas

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:	NCT00012246 History of Changes
Other Study ID Numbers:	CDR0000068497; UTMB-00-297; NCI-931
First Posted:	January 27, 2003
Last Update Posted:	May 16, 2013
Last Verified:	May 2013

Keywords provided by The University of Texas Medical Branch, Galveston:

stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; recurrent esophageal cancer; adenocarcinoma of the stomach; small intestine adenocarcinoma; localized gallbladder cancer; unresectable gallbladder cancer; recurrent gallbladder cancer; localized extrahepatic bile duct cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; adenocarcinoma of the esophagus; adenocarcinoma of the colon

Additional relevant MeSH terms:

Colorectal Neoplasms; Adenocarcinoma; Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases	Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases