Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027833
Recruitment Status : Unknown
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy.

PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: ALVAC-CEA-B7.1 vaccine Biological: tetanus toxoid Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2

Detailed Description:


  • Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma.
  • Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks.

Two weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I.
  • Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy, patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once weekly on weeks 1-3 and 6.

PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma
Study Start Date : December 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic colorectal adenocarcinoma
  • No clinically active CNS metastases



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 6 months


  • Lymphocyte count at least 1,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST/ALT less than 3 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present)
  • No hepatocellular dysfunction
  • No cirrhosis


  • Creatinine less than 2.5 mg/dL


  • No uncontrolled coronary artery disease
  • No symptomatic congestive heart failure


  • No uncontrolled chronic obstructive lung disease


  • No unsolved bowel obstruction or subobstruction
  • No uncontrolled Crohn's disease
  • No ulcerative colitis
  • No concurrent chronic diarrhea


  • HIV negative
  • No immunocompromised patients
  • No diagnosis of altered immune function, including:

    • Lupus erythematosus
    • Sjogren's syndrome
    • Scleroderma
    • Myasthenia gravis
    • Goodpasture's disease
    • Addison's disease
    • Hashimoto's thyroiditis
    • Active Graves' disease
  • No known allergy to egg products or neomycin
  • No prior adverse reaction to tetanus toxoid-containing vaccines


  • No significant comorbid medical function
  • No uncontrolled infection
  • No unstable diabetes mellitus
  • No uncontrolled thyroid function abnormalities
  • No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix
  • No other medical illness or mental status that would preclude study participation
  • No prior severe toxicity to adjuvant chemotherapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation


Biologic therapy:

  • No prior CEA-directed immunotherapy
  • No other concurrent immunotherapy


  • At least 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent daily use of systemic steroids
  • No concurrent nonsubstitutional hormonal therapy


  • No prior radiotherapy to more than 50% of all nodal groups
  • No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve


  • No prior major organ allograft
  • Recovered from prior surgery


  • At least 28 days since prior investigational products
  • No other concurrent investigational products

Information from the National Library of Medicine

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 identifier (NCT number): NCT00027833

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35243
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Scranton Hematology-Oncology
Scranton, Pennsylvania, United States, 18510
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Howard L. Kaufman, MD Herbert Irving Comprehensive Cancer Center

Publications of Results: Identifier: NCT00027833     History of Changes
Other Study ID Numbers: CDR0000069082
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: September 2003

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors