Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
Recruitment status was: Active, not recruiting
|Soft Tissue Sarcoma Mesothelioma||Drug: Azacitidine In Combination With Temozolomide||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma|
- The primary endpoint is dose limiting toxicity. [ Time Frame: Study Completion ]
- Clinical response, time to progression and overall survival. [ Time Frame: Study Completion ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Drug: Azacitidine In Combination With Temozolomide
The primary objective of the study is to determine the clinical and laboratory toxicities as well as acceptability/tolerance of this dose schedule of combined drug treatment with temozolomide and azacitidine.
Secondary objectives include determination of biochemical response to azacitidine as defined as change in methylation status. We will specifically be looking at changes in genome wide methylation patterns as determined by two high-throughput platforms:
- A single nucleotide polymorphism chip-based method (MSNP) for genome wide epigenetic profiling
- CpG island promoter arrays will be performed to focus on promoter methylation status.
We will also monitor clinical response, time to progression and overall survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629343
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert N Taub, MD||Columbia University|