Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084981
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2004-06-10
Brief Title:
Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with non-small cell lung cancer Drugs used in chemotherapy such as decitabine and valproic acid work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of decitabine and valproic acid in patients with non-small cell lung cancer
II Determine the recommended phase II dose of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the ability of this regimen to lead to biological changes in tumor and surrogate tissues in these patients including hypomethylation of target genes known to be methylated in NSCLC CDKN2 APC BMP3B CDH1 and RASSF1A in biopsy specimens and surrogate tissues peripheral blood mononuclear cells PBMC and plasmaserum DNA acetylation and methylation changes in histones from tumor and surrogate tissues PBMC and oral epithelial cells inhibition of histone deacetylase HDAC activity in peripheral blood pharmacokinetic analysis of Decitabine and Valproic Acid DNA methyltransferase 1 DNMT1 protein loss in PBMC and buccal cells response of hemoglobin F in patients with non-hematologic conditions to DNMT and HDAC inhibition and preliminary evidence of antitumor activity in non-small cell lung cancer
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-10 and oral valproic acid three times daily on days 5-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of decitabine and valproic acid until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined an additional 6 patients are treated at that dose
I Determine the safety and tolerability of decitabine and valproic acid in patients with non-small cell lung cancer
II Determine the recommended phase II dose of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the ability of this regimen to lead to biological changes in tumor and surrogate tissues in these patients including hypomethylation of target genes known to be methylated in NSCLC CDKN2 APC BMP3B CDH1 and RASSF1A in biopsy specimens and surrogate tissues peripheral blood mononuclear cells PBMC and plasmaserum DNA acetylation and methylation changes in histones from tumor and surrogate tissues PBMC and oral epithelial cells inhibition of histone deacetylase HDAC activity in peripheral blood pharmacokinetic analysis of Decitabine and Valproic Acid DNA methyltransferase 1 DNMT1 protein loss in PBMC and buccal cells response of hemoglobin F in patients with non-hematologic conditions to DNMT and HDAC inhibition and preliminary evidence of antitumor activity in non-small cell lung cancer
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-10 and oral valproic acid three times daily on days 5-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of decitabine and valproic acid until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined an additional 6 patients are treated at that dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |
| NCI-2012-01451 | REGISTRY | None | None |
| NCI-6237 | None | None | None |
| OSU-2003C0087 | None | None | None |
| OSU-0346 | None | None | None |
| CDR0000367115 | None | None | None |
| OSU 0346 | OTHER | None | None |
| 6237 | OTHER | None | None |