Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
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| ClinicalTrials.gov Identifier: NCT00012246 |
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Recruitment Status :
Terminated
(Administratively Terminated)
First Posted : January 27, 2003
Last Update Posted : May 16, 2013
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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 |
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 : | 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 |
- Production of CAP 1-6D T cells
- Production of cytotoxic T cells
- Antitumor response
- Frequency and severity of toxic effects
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012246
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| Study Chair: | Robert P. Whitehead, MD | University of Texas |
| 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 Key Record Dates |
| Last Update Posted: | May 16, 2013 |
| Last Verified: | May 2013 |
Keywords provided by The University of Texas Medical Branch, Galveston:
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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:
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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 |