Neoplasms

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Neoplasms, Connective and Soft Tissue

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Adenoma

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Soft Tissue Sarcoma

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Azacitidine

Temozolomide

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Alkylating Agents

Azacitidine In Combination With Temozolomide

Robert N Taub, MD

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.

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma

Schering-Plough

Celgene Corporation

Columbia University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide	NCT00629343	Soft Tissue Sar... Mesothelioma	Azacitidine In ...	18 Years -	Columbia University
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide	NCT00629343	Soft Tissue Sar... Mesothelioma	Azacitidine In ...	18 Years -	Columbia University

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