Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077181
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-02-10
Brief Title:
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Triapine in Combination With High Dose Ara-C Hi-DAC in Patients With Advanced Hematologic Malignancies
Status:
COMPLETED
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:
Drugs used in chemotherapy such as cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of 3-AP Triapine administered with high-dose cytarabine in patients with advanced hematologic malignancies
SECONDARY OBJECTIVES
I Determine the clinical activity of this regimen in these patients II Determine the effect of treatment with 3-AP Triapine on intracellular levels of cytarabine in these patients
OUTLINE This is a dose-escalation study of 3-AP Triapine
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP Triapine IV over 2 hours on days 2-5 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP Triapine 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
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 6-48 patients 3-24 per stratum will be accrued for this study within 15-24 months
I Determine the maximum tolerated dose of 3-AP Triapine administered with high-dose cytarabine in patients with advanced hematologic malignancies
SECONDARY OBJECTIVES
I Determine the clinical activity of this regimen in these patients II Determine the effect of treatment with 3-AP Triapine on intracellular levels of cytarabine in these patients
OUTLINE This is a dose-escalation study of 3-AP Triapine
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP Triapine IV over 2 hours on days 2-5 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP Triapine 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
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 6-48 patients 3-24 per stratum will be accrued for this study within 15-24 months
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 |
|---|---|---|---|
| CDR0000349659 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069852 |
| UCCRC-12806B | None | None | None |
| U01CA069852 | NIH | None | None |