Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089089
Status:
TERMINATED
Last Update Posted:
2013-01-07
First Post:
2004-08-04
Brief Title:
Decitabine in Treating Patients With Advanced Refractory Solid Tumors or Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Prolonged Low Dose Decitabine 5-Aza-Deoxycytidine NSC 127716 in Patients With Biopsiable Advanced Cancers Refractory to Standard Therapy
Status:
TERMINATED
Status Verified Date:
2013-01
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 in treating patients with metastatic or unresectable refractory solid tumors or lymphomas Drugs used in chemotherapy such as decitabine work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of single agent decitabine and its toxicity using this schedule in this population of patients with solid tumors or lymphomas
II Definition of the dose at which tumor DNA demethylation is optimum III Definition of the dose at which peripheral blood mononuclear cell PBMN demethylation is optimal
IV Definition of decitabine pharmacokinetics and correlation of plasma concentrations with hypomethylation effects
SECONDARY OBJECTIVES
I Preliminary assessment of decitabine efficacy objective response
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-5 or on days 1-5 and 8-12 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 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
I To determine the maximum tolerated dose of single agent decitabine and its toxicity using this schedule in this population of patients with solid tumors or lymphomas
II Definition of the dose at which tumor DNA demethylation is optimum III Definition of the dose at which peripheral blood mononuclear cell PBMN demethylation is optimal
IV Definition of decitabine pharmacokinetics and correlation of plasma concentrations with hypomethylation effects
SECONDARY OBJECTIVES
I Preliminary assessment of decitabine efficacy objective response
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-5 or on days 1-5 and 8-12 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 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
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 |
|---|---|---|---|
| 2004-0040 | None | None | None |
| U01CA062461 | NIH | None | httpsreporternihgovquickSearchU01CA062461 |