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Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

This study has been terminated.
(Administratively Terminated)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00012246
First received: March 3, 2001
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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.


Condition Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Production of CAP 1-6D T cells [ Designated as safety issue: No ]
  • Production of cytotoxic T cells [ Designated as safety issue: Yes ]
  • Antitumor response [ Designated as safety issue: No ]
  • Frequency and severity of toxic effects [ Designated as safety issue: Yes ]
Enrollment: 7
Study Start Date: July 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012246

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

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 
Study First Received: March 3, 2001
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

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
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
Bile Duct Diseases

ClinicalTrials.gov processed this record on September 26, 2016