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

NCT00027833 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-01-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ALVAC-CEA-B7.1 vaccine

BIOLOGICAL

tetanus toxoid

DRUG

FOLFIRI regimen

DRUG

fluorouracil

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Herbert Irving Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Howard L. Kaufman, MD · Herbert Irving Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00027833 on ClinicalTrials.gov