Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to learn if temozolomide alone or given with
pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want
to study the safety of these 2 treatments.
Objectives:
1. To determine the anti-tumor activity (pathological response CR+PR) and toxicity of
temozolomide (TMZ) alone or in combination with pegylated interferon alpha-2b (PGI) in
patients with resectable stage IIIC or stage IV (M1a) metastatic melanoma prior to
definitive surgical resection.
2. To determine the relapse-free survival, overall survival and the impact of tumor
response to chemotherapy in these patients.
3. To differentiate the in vivo treatment effects of TMZ alone vs.TMZ plus PGI and
correlate with clinical outcome by analysis the pre- and post-treatment tumors and
peripheral blood mononuclear cells with respect to:
1) Known cellular and molecular markers of apoptosis and cell proliferation, 2) Promotor
methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT), 3)
DNA sequence variability of tumor suppressor genes and DNA repair enzymes, 4) Tumor genomic
expression profiles analysis by complementary DNA (cDNA) microarray and protein array