Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064090
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-07-08
Brief Title:
3-AP and Cytarabine in Treating Patients With Hematologic Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2008-08
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 such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer
PURPOSE Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer
Detailed Description:
OBJECTIVES
Determine the feasibility tolerability and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies
Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients
Determine the biological effects of 3-AP and its interaction with cytarabine in these patients
OUTLINE This is a pilot dose-escalation study of cytarabine
Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a response may receive an additional course as consolidation therapy
Cohorts of 3-6 patients receive escalating doses of cytarabine 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 an additional 10 patients receive treatment at that dose
PROJECTED ACCRUAL Approximately 20-25 patients will be accrued for this study
Determine the feasibility tolerability and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies
Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients
Determine the biological effects of 3-AP and its interaction with cytarabine in these patients
OUTLINE This is a pilot dose-escalation study of cytarabine
Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a response may receive an additional course as consolidation therapy
Cohorts of 3-6 patients receive escalating doses of cytarabine 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 an additional 10 patients receive treatment at that dose
PROJECTED ACCRUAL Approximately 20-25 patients 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 |
|---|---|---|---|
| MDA-DM-030096 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000306465 | REGISTRY | None | None |