NCT00027833

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 6, 2014

Status Verified

September 1, 2003

First QC Date

December 7, 2001

Last Update Submit

January 3, 2014

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

ALVAC-CEA-B7.1 vaccineBIOLOGICAL
tetanus toxoidBIOLOGICAL
FOLFIRI regimenDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35243, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Scranton Hematology-Oncology

Scranton, Pennsylvania, 18510, United States

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 18676757RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Tetanus ToxoidFluorouracilIrinotecanLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex MixturesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Howard L. Kaufman, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

December 1, 2001

Last Updated

January 6, 2014

Record last verified: 2003-09

Locations

US(10)CA(3)