At a glance
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A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma
In Brief
A Phase 1 clinical trial evaluating Azacitidine and Temozolomide for Soft Tissue Sarcoma and Mesothelioma. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Azacitidine will be delivered sub-cutaneously for 5 days
Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days