Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
This study has been terminated.
(Administratively Terminated)
Sponsor:
The University of Texas, Galveston
Collaborator:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00012246
First received: March 3, 2001
Last updated: May 15, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
familial cold autoinflammatory syndrome
MedlinePlus related topics:
Cancer
Colorectal Cancer
Esophageal Cancer
Esophagus Disorders
Intestinal Cancer
Pancreatic Cancer
Stomach Cancer
Drug Information available for:
Sargramostim
U.S. FDA Resources
Further study details as provided by The University of Texas, 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) |
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
- 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
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, Galveston
Investigators
| Study Chair: | Robert P. Whitehead, MD | University of Texas |
More Information
Additional Information:
No publications provided
| Responsible Party: | The University of Texas, 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, 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:
|
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 May 23, 2013