Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura

Phase 1

Completed

• Conditions: Esophageal Cancer; Lung Cancer; Malignant Mesothelioma; Metastatic Cancer

• Registration Number: NCT00019825
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-07
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States