A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients
This is a Phase I, single site study to evaluate the immunological effects of autologous DC
transduced with the MART-1, tyrosinase and MAGE-A6 (melanoma associated antigens, MAA) genes
in 30 subjects with recurrent, unresectable stage III, IV metastatic melanoma (M1a, M1b,
M1c). AdVTMM2-transduced DC, 10e7, will be given intradermally (i.d.) every two weeks for a
total of 3 vaccines.
After the DC vaccines, subjects will be randomized to either receive a boost of high dose
IFNa2b or no boost.
Subjects randomized to receive the IFNa2b boost will receive Interferon-a2b, 20 MU/m2/d
(rounded to the nearest 1 million units) administered intravenously for 5 consecutive days
(Monday through Friday) every week for 4 weeks (induction). Administration will begin 30
days after the 3rd vaccine.
The end-points of this study are local and systemic toxicity, immunological response,
generation of determinant spreading and anti-tumor immunity, and clinical response.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Types of adverse events associated with this Multiple Antigen-Engineered DC vaccine at the injection site and systemically.
John M Kirkwood, MD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|