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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Production of CAP 1-6D T cells

Safety Issue:

No

Principal Investigator

Robert P. Whitehead, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068497

NCT ID:

NCT00012246

Start Date:

July 2002

Completion Date:

July 2006

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Small Intestine Cancer
  • 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
  • adenocarcinoma of the rectum
  • adenocarcinoma of the gallbladder
  • adenocarcinoma of the extrahepatic bile duct
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • 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

Name

Location

University of Texas Medical BranchGalveston, Texas  77555-1329