ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

This study has been completed.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
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
Brief Summary

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.

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 Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Active Control
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Colorectal Cancer
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastric Cancer
Pancreatic Cancer
Small Intestine Cancer
Intervention  Drug: carcinoembryonic antigen peptide 1-6D
Drug: incomplete Freund's adjuvant
Drug: sargramostim
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  July 2002
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00012246
Organization ID CDR0000068497
Secondary IDs †† UTMB-00-297, NCI-931
Study Sponsor  University of Texas
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Robert P. Whitehead, MD     University of Texas    
Information Provided By National Cancer Institute (NCI)
Verification Date January 2006
First Received Date  March 3, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers