Vaccine Therapy in Treating Patients With Metastatic Cancer
RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy.
Adult Soft Tissue Sarcoma
Drug: MAGE-12 peptide vaccine
Drug: Montanide ISA-51
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen|
|Study Start Date:||July 2000|
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 treatment arms.
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 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020267
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Francesco M. Marincola||National Cancer Institute (NCI)|