Breast Cancer Clinical Trial
Official title:
Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients
who have metastatic or recurrent 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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