Phase I/II Trial of the Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
- 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.
- To determine pharmacokinetics of the combination of TMZ and DAC in patients with
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Safety, tolerability and Phase II recommended dose of the combination of TMZ + DAC. Phase II: Objective response rate
No more than a total of 18 patients will be treated in the phase I portion of the trial, and the MTD cannot be determined with fewer than 8 patients. The MTD is defined to be the highest dose level at which no more than 1 of 6 patients experience DLTs.
Hussein Tawbi, MD
University of Pittsburgh
United States: Institutional Review Board
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|