Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer
OBJECTIVES: I. Determine the optimum biologic dose of MVF-HER-2(628-647)-CRL 1005 vaccine
that will induce anti-HER-2 antibody in patients with metastatic or recurrent cancer. II.
Characterize the nature and severity of toxicity of this drug in these patients. III.
Document any clinical responses to this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive MVF-HER-2(628-647)-CRL 1005
vaccine intramuscularly on days 1 and 29. Cohorts of 5 patients receive escalating doses of
MVF-HER-2(627-647)-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting
toxicity. Patients are followed on days 43 and 57 and every 2 months for at least 1 year.
PROJECTED ACCRUAL: Approximately 5-25 patients will be accrued for this study.
Primary Purpose: Treatment
Pierre L. Triozzi, MD
University of Alabama at Birmingham
United States: Federal Government