Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen
OBJECTIVES: I. Determine the toxicity profile of MAGE-12 peptide vaccine in patients with
refractory metastatic cancer that expresses MAGE-12 antigen.
II. Determine whether an immunologic response, as measured by an in vitro sensitization
assay, can be obtained after administration of this regimen in these patients.
III. Determine a frequency of administration for this regimen based on immunologic response
in these patients.
IV. Determine other immunologic parameters in these patients treated with this regimen.
V. Determine the clinical response rate in these patients treated with this regimen.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease
(metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of two
Arm I: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant
subcutaneously (SC) weekly for 4 doses.
Arm II: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC
once every 3 weeks for 4 doses.
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8
hours, beginning on the day after each immunization and continuing for up to 4 days.
Patients achieving stable disease or a mixed, partial, or complete response continue on
vaccine therapy alone for up to 24 total doses.
Patients are followed at 3 weeks.
A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 1
Primary Purpose: Treatment
Francesco M. Marincola
National Cancer Institute (NCI)
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|