Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00629343|
Recruitment Status : Unknown
Verified November 2012 by Columbia University.
Recruitment status was: Active, not recruiting
First Posted : March 6, 2008
Last Update Posted : November 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Mesothelioma||Drug: Azacitidine In Combination With Temozolomide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||August 2014|
Drug: Azacitidine In Combination With Temozolomide
- The primary endpoint is dose limiting toxicity. [ Time Frame: Study Completion ]
- Clinical response, time to progression and overall survival. [ Time Frame: Study Completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629343
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert N Taub, MD||Columbia University|