Clinical Trials for Mesothelioma Patients—A Study of Decitabine and FR901228: Study Objectives

Read about the objectives for a current clinical trial about the use of Decitabine and FR901228 for patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Objectives:
Determine the pharmacokinetics, toxicity, and maximum tolerated dose of decitabine and FR901228 (depsipeptide) in patients with unresectable pulmonary, esophageal, or pleural malignancies.
Determine serologic response to NY-ESO-1 in these patients before and after receiving this regimen.
Evaluate apoptosis in tumor biopsies of these patients before and after receiving this regimen.

Outline:
This is a dose-escalation study.

Patients receive decitabine IV continuously on days 1-3 and FR901228 (depsipeptide) IV over 4 hours on days 4 and 10. Courses repeat every 33-36 days in the absence of disease progression or unacceptable toxicity.

Sequential dose escalation of decitabine is followed by sequential dose escalation of FR901228. Cohorts of 3-6 patients receive escalating doses of decitabine and then FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Once the MTD is determined, two additional cohorts (6 lung cancer and 6 mesothelioma patients) receive decitabine and FR901228 as above at the MTD. These patients also receive oral celecoxib twice daily on days 4-34 of each course.

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