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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALVAC-CEA-B7.1 vaccine
tetanus toxoid
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Lombardi Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • University of Chicago Cancer Research Center
  • Herbert Irving Comprehensive Cancer Center
  • Earle A. Chiles Research Institute at Providence Portland Medical Center
  • Fox Chase Cancer Center
  • Scranton Hematology-Oncology
  • Ottawa Regional Cancer Centre
  • Princess Margaret Hospital
  • McGill University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027833
Brief Title
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Unknown status
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ALVAC-CEA-B7.1 vaccine
Intervention Type
Biological
Intervention Name(s)
tetanus toxoid
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard L. Kaufman, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Earle A. Chiles Research Institute at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Scranton Hematology-Oncology
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18676757
Citation
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.
Results Reference
result

Learn more about this trial

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

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