A Phase II Trial of High Dose Interleukin-2 (HDIL-2) with Recombinant MAGE-A3 Protein Combined with Adjuvant System AS15 (recMAGE-A3 + AS15) in Patients with Unresectable or Metastatic Melanoma
The goal of this pre-screening part of this clinical research study is to collect a blood and a tumor tissue sample from patients with unresectable or metastatic melanoma. If you agree to take part in the pre-screening part of this study, a leftover tumor tissue sample from a previous surgery or biopsy will be collected. The tumor tissue sample will be sent to GSK Biologicals for testing to look at the MAGE-A3 expressing gene. By studying this gene, researchers hope to learn more about how unresectable or metastatic melanoma may respond to the study drugs that are given in the main part of this study. You will also have blood (about 1 teaspoon drawn to test for levels of antinuclear antibody (ANA). An additional teaspoon of blood will be drawn at the end of the main part of this study. ANA is a protein found in the body that can attack the body's own tissue like it was a foreign substance. High levels of ANA in the body may mean that you have an autoimmune disease.
Treatment Location: N/A
STUDY OBJECTIVES Primary Objectives To evaluate the objective response rate induced by the concurrent administration of HDIL-2 and (recMAGE-A3 + AS15 ASCI) in patients with MAGE-A3-positive unresectable or metastatic melanoma. To evaluate the safety and toxicity profile of HDIL-2 in combination with (recMAGE-A3 + AS15 ASCI) in patients with MAGE-A3-positive unresectable or metastatic melanoma Secondary objectives To evaluate the rate of stable disease, progression-free survival and the overall survival of patients with MAGE-A3-positive unresectable or metastatic melanoma who received the combination of HDIL-2 and (recMAGE-A3 + AS15 ASCI). To evaluate the immune response generated by the treatment of HDIL-2 in combination with recMAGe-A3 + AS15 ASCI in patients with MAGE A3-positive unresectable or metastatic melanoma. To evaluate the correlation of the predictive value of the gene signature with the clinical response to the study treatment and the clinical activity of those presenting the predictive gene signature.
IRB Review and Approval Date: 02/22/2011
Recruitment Status: Closed
Projected Accrual: N/A