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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic colorectal adenocarcinoma

- No clinically active CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 6 months

Hematopoietic:

- 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

Hepatic:

- 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

Renal:

- Creatinine less than 2.5 mg/dL

Cardiovascular:

- No uncontrolled coronary artery disease

- No symptomatic congestive heart failure

Pulmonary:

- No uncontrolled chronic obstructive lung disease

Gastrointestinal:

- No unsolved bowel obstruction or subobstruction

- No uncontrolled Crohn's disease

- No ulcerative colitis

- No concurrent chronic diarrhea

Immunologic:

- 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

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior CEA-directed immunotherapy

- No other concurrent immunotherapy

Chemotherapy:

- 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

Radiotherapy:

- 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

Surgery:

- No prior major organ allograft

- Recovered from prior surgery

Other:

- At least 28 days since prior investigational products

- No other concurrent investigational products

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Howard L. Kaufman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069082

NCT ID:

NCT00027833

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Adenocarcinoma
  • Colorectal Neoplasms
  • Tetanus

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Lombardi Cancer CenterWashington, District of Columbia  20007
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967
Scranton Hematology-OncologyScranton, Pennsylvania  18510