Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like)Human Epidermal Growth Factor Receptor 2 (HER-2) B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors
PRIMARY OBJECTIVES:
I. To perform early phase clinical trial assessing safety and clinical toxicity of
immunization, and as well as to establish an optimal biological dose (OBD) of combination
vaccines with n-muramyldipeptide derivative (nor-MDP) as adjuvant emulsified in Montanide
(ISA 720).
II. To establish whether an OBD of two combination vaccines is achieved. III. To measure
both humoral and cellular immune responses including the specificity, class and kinetics of
anti-human epidermal growth factor receptor-2 (HER-2) peptide.
IV. To evaluate whether the combination of HER-2 epitopes show therapeutic benefit, provide
synergistic and/or additive effects and to enumerate mechanisms of action.
SECONDARY OBJECTIVES:
I. To collect and analyze post-immune sera and peripheral blood cells for additional six
months post the last injection.
II. To document any clinical responses that may occur.
OUTLINE: This is a dose-escalation study.
Patients receive a HER2/neu peptide vaccine comprising measles virus epitope MVF-HER-2
(266-296) and MVF-HER-2 (597-626) emulsified with nor-MDP in ISA 720 intramuscularly (IM) on
day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Type and duration of immune response measured over time to repeat vaccine administration
Immune response will be defined by Enzyme-linked immunosorbent assay (ELISA), Flow cytometry, T-cell proliferation and cytokine. The magnitude of antibody levels will be assessed to the vaccine and HER-2 over-expressing cells (e.g.,BT474). Lymphoproliferative responses will be assessed by a non radioactive cell proliferation assay Bioplex human isotyping kit will be used to assess antibody types and cytokine profiles.
up to 6 months
No
Pravin Kaumaya, PhD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
OSU-09138
NCT01376505
June 2011
Name | Location |
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Ohio State University Medical Center | Columbus, Ohio 43210 |