Malignant Melanoma Clinical Trial
Official title:
Phase I/II Trial of the Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
Primary Objectives:
- Phase I: To determine the safety, tolerability, and Phase II recommended dose of the
combination of extended schedule TMZ and DAC.
- Phase II: To determine the efficacy, as measured by overall response rate, of the
combination of extended schedule TMZ and DAC given at the Phase II recommended dose to
patients with metastatic melanoma.
Secondary Objectives:
- To determine pharmacokinetics of the combination of TMZ and DAC in patients with
metastatic melanoma.
- To determine, in peripheral blood mononuclear cells (PBMC) and tumor tissue, the
pharmacodynamic effects of the combination of TMZ and DAC on promoter methylation and
expression of selected genes and correlate these with response.
- To determine the progression-free survival of patients treated with the combination of
TMZ and DAC.
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