Vaccine Therapy in Treating Patients With Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00020267|
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Adult Soft Tissue Sarcoma Colorectal Cancer Bone Cancer Ovarian Sarcoma Melanoma Colon Cancer Rectal Cancer Breast Cancer Eye Cancer Uterine Sarcoma||Drug: interleukin-2 Drug: MAGE-12 peptide vaccine Drug: Montanide ISA-51||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020267
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Francesco M. Marincola||National Cancer Institute (NCI)|