NCT00629343

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The investigators 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. The investigators will also monitor clinical response, time to progression and overall survival.

Conditions

• Soft Tissue Sarcoma
• Mesothelioma

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacitidine will be delivered sub-cutaneously for 5 days
DRUG	Temozolomide	Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-03-06
• Last updated: 2025-06-05
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States