Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine the pharmacokinetics, toxicity, and maximum tolerated dose of decitabine in patients with unresectable primary small cell or non-small cell lung cancer, unresectable esophageal cancer, or malignant pleural mesothelioma. * Measure the expression of NY-ESO-1 in tissue samples of these patients before and after receiving this drug. * Assess the serologic response to NY-ESO-1 in these patients before and after receiving this drug. * Measure the expression of p16 tumor suppressor gene in these patients before and after receiving this drug. OUTLINE: This is a dose-escalation study for each stratification group. Patients are stratified according to number of prior therapies (2 or fewer vs 3 or more). Patients receive decitabine IV continuously on days 1-3. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of the second course receive 2 additional courses. Cohorts of 3-6 patients receive escalating doses of decitabine 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 for a particular stratum, additional patients from that stratum are treated at the MTD. Patients are followed for 1 month. PROJECTED ACCRUAL: A maximum of 72 patients (36 per stratum) will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
