Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
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|ClinicalTrials.gov Identifier: NCT00019825|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer||Drug: decitabine||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients|
|Study Start Date :||October 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019825
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||David S. Schrump, MD||NCI - Surgery Branch|