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

Phase 2 Unknown Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) · collab

RandomizedOpen-labelTreatment

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.

Timeline

Start: 2001-12
Primary completion: —
Completion: —

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALVAC-CEA-B7.1	Unknown	—	Subcutaneous
Subject	tetanus toxoid	Vaccine	—	Subcutaneous
Background	Irinotecan	Small molecule	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications