Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019825
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0012 | None | None | None |
| NCI-99-C-0129 | None | None | None |