Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00012246
• Other study ID #: CDR0000068497
• Secondary ID: UTMB-00-297NCI-9
• Status: Terminated
• Phase: Phase 2
• First received: March 3, 2001
• Last updated: May 15, 2013
• Start date: July 2002
• Est. completion date: July 2006

Study information

• Verified date: May 2013
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Intervention

Biological:
• carcinoembryonic antigen peptide 1-6D

• incomplete Freund's adjuvant

• sargramostim

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of CAP 1-6D T cells			No
Primary	Production of cytotoxic T cells			Yes
Primary	Antitumor response			No
Primary	Frequency and severity of toxic effects			Yes