Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459212
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2007-04-09
Brief Title:
GTI-2040 in Treating Patients With Relapsed Refractory or High-Risk Acute Leukemia High-Grade Myelodysplastic Syndromes or Refractory or Blastic Phase Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Pharmacodynamic Study of GTI-2040 NSC 722929 IND 67368 in Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2013-04
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 GTI-2040 in treating patients with relapsed refractory or high-risk acute leukemia high-grade myelodysplastic syndromes or refractory or blastic phase chronic myelogenous leukemia Drugs used in chemotherapy such as GTI-2040 work in different ways to stop the growth of cancer or abnormal cells either by killing the cells or by stopping them from dividing
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of GTI-2040 in patients with relapsed refractory or high-risk acute leukemia high-grade myelodysplastic syndromes or refractory or blastic phase chronic myelogenous leukemia
II Assess the toxicity and efficacy of this drug in these patients III Assess plasma and intracellular pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive GTI-2040 IV continuously on days 1-4 and 15-18 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of GTI-2040 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
Blood samples are collected on days 1 4 15 and 19 of course 1 for pharmacokinetic studies Samples are analyzed by proteomic assay dCTP pool measurement and real-time polymerase chain reaction for mRNA of RRM2 RRM1 and p53R2
I Determine the maximum tolerated dose of GTI-2040 in patients with relapsed refractory or high-risk acute leukemia high-grade myelodysplastic syndromes or refractory or blastic phase chronic myelogenous leukemia
II Assess the toxicity and efficacy of this drug in these patients III Assess plasma and intracellular pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive GTI-2040 IV continuously on days 1-4 and 15-18 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of GTI-2040 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
Blood samples are collected on days 1 4 15 and 19 of course 1 for pharmacokinetic studies Samples are analyzed by proteomic assay dCTP pool measurement and real-time polymerase chain reaction for mRNA of RRM2 RRM1 and p53R2
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 |
|---|---|---|---|
| U01CA062505 | NIH | None | httpsreporternihgovquickSearchU01CA062505 |
| PHI-57 | None | None | None |
| CDR0000539257 | None | None | None |