Soft Tissue Sarcoma Clinical Trial
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 purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
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:
1. A single nucleotide polymorphism chip-based method (MSNP) for genome wide epigenetic
profiling
2. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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