Lung Cancer Clinical Trial
Official title:
Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who
have unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.
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.
;
Primary Purpose: Treatment
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