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)

December 7, 2001
January 27, 2003
January 6, 2014
December 2001
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Complete list of historical versions of study NCT00027833 on Archive Site
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Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
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

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.


  • 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.

Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: ALVAC-CEA-B7.1 vaccine
  • Biological: tetanus toxoid
  • Drug: FOLFIRI regimen
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
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Kaufman HL, Lenz HJ, Marshall J, Singh D, Garett C, Cripps C, Moore M, von Mehren M, Dalfen R, Heim WJ, Conry RM, Urba WJ, Benson AB 3rd, Yu M, Caterini J, Kim-Schulze S, Debenedette M, Salha D, Vogel T, Elias I, Berinstein NL. Combination chemotherapy and ALVAC-CEA/B7.1 vaccine in patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Aug 1;14(15):4843-9. doi: 10.1158/1078-0432.CCR-08-0276.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Howard L. Kaufman, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP