Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract - Full Text View

Sponsor:	University of Texas
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00012246

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 II

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:

MedlinePlus related topics: Cancer Colorectal Cancer Esophageal Cancer Esophagus Disorders Intestinal Cancer Pancreatic Cancer Stomach Cancer

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Montanide ISA 51 Freund's adjuvant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Study Start Date:

July 2002

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
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
HLA-A2+

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

SWOG 0-1

Life expectancy:

See Disease Characteristics

Hematopoietic:

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3
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

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

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

University of Texas

National Cancer Institute (NCI)

Investigators

Study Chair:

Robert P. Whitehead, MD

University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Adenocarcinoma
Colorectal Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Duodenal Diseases

ClinicalTrials.gov processed this record on February 12, 2012