Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030615
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2002-02-14
Brief Title:
Decitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of The Toxicities Biologic And Clinical Effects Of Daily 5 Aza 2Deoxycytidine DAC NSC 127716 IND 50733 For Four Weeks In Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-02
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 advanced solid tumors that have not responded to previous treatment Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors
II Determine the toxic effects of this drug in these patients III Determine the dose of this drug with biologic activity in these patients IV Determine the pharmacokinetics of this drug in these patients V Determine clinical response to this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 2 weeks
I Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors
II Determine the toxic effects of this drug in these patients III Determine the dose of this drug with biologic activity in these patients IV Determine the pharmacokinetics of this drug in these patients V Determine clinical response to this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 2 weeks
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 |
|---|---|---|---|
| OC-01-01 | None | None | None |
| U01CA062505 | NIH | None | None |
| CDR0000069182 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062505 |