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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Herbert Irving Comprehensive Cancer Center
Study ID
NCT00027833
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALVAC-CEA-B7.1 vaccine — BIOLOGICAL
  • tetanus toxoid — BIOLOGICAL
  • FOLFIRI regimen — DRUG
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG

Study Details

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.

Key Dates

Start date
Dec 31, 2001
Status verified
Sep 2003

Study Design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Locations (10)

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