- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012246
Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
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
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 Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Production of CAP 1-6D T cells
|
Production of cytotoxic T cells
|
Antitumor response
|
Frequency and severity of toxic effects
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage III colon cancer
- stage IV pancreatic cancer
- stage IV gastric cancer
- recurrent gastric cancer
- small intestine adenocarcinoma
- unresectable gallbladder cancer
- recurrent gallbladder cancer
- unresectable extrahepatic bile duct cancer
- recurrent extrahepatic bile duct cancer
- recurrent small intestine cancer
- stage III gastric cancer
- stage II esophageal cancer
- stage III esophageal cancer
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
- recurrent esophageal cancer
- stage II rectal cancer
- stage III rectal cancer
- stage II colon cancer
- stage III pancreatic cancer
- stage IV esophageal cancer
- stage II gastric cancer
- stage II pancreatic cancer
- adenocarcinoma of the gallbladder
- adenocarcinoma of the extrahepatic bile duct
- localized extrahepatic bile duct cancer
- localized gallbladder cancer
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Intestinal Diseases
- Esophageal Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Cholangiocarcinoma
- Esophageal Neoplasms
- Intestinal Neoplasms
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Sargramostim
- Freund's Adjuvant
Other Study ID Numbers
- CDR0000068497
- UTMB-00-297
- NCI-931
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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