Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Phase 2 Completed 56 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.

Timeline

Start: 2001-12
Primary completion: 2007-03
Completion: 2010-06

Outcome

Missed primary endpoint

paper Anti-idiotype monoclonal antibody vaccine therapy with CeaVac and TriAb as an adjuvant to curative resection of colorectal cancer hepatic metastases is well tolerated but did not improve 2-year recurrence-free survival PMID 18008108 ↗

Publications

Results Posner MC, Niedzwiecki D, Venook AP, Hollis DR, Kindler HL, Martin EW, Schilsky RL, Goldberg RM, Mayer RJ. A phase II prospective multi-institutional trial of adjuvant active specific immunotherapy following curative resection of colorectal cancer hepatic metastases: cancer and leukemia group B study 89903. Ann Surg Oncol. 2008 Jan;15(1):158-64. doi: 10.1245/s10434-007-9654-7. Epub 2007 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	11D10	Monoclonal antibody	2 mg	Other
Subject	3H1	Monoclonal antibody	2 mg	Other