Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070551
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-10-03
Brief Title:
GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of GTI2040 NSC 722929 IND 67368 in Combination With High-dose Cytarabine in Refractory or Relapsed Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2013-06
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 and high-dose cytarabine in treating patients with refractory or relapsed acute myeloid leukemia GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die Giving GTI-2040 together with cytarabine may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of GTI-2040 and high-dose cytarabine in patients with relapsed or refractory acute myeloid leukemia
SECONDARY OBJECTIVES
I Determine the therapeutic response in patients treated with this regimen II Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to age under age 60 vs age 60 and over Patients are assigned to 1 of 2 strata
Stratum I under age 60 Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 2 hours twice daily on days 2 4 and 6
Stratum II age 60 and over Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 4 hours once daily on days 2-6
In both strata treatment continues in the absence of unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of GTI-2040 and high-dose cytarabine 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
PROJECTED ACCRUAL A total of 6-51patients will be accrued for this study within 2-16 months
I Determine the maximum tolerated dose and recommended phase II dose of GTI-2040 and high-dose cytarabine in patients with relapsed or refractory acute myeloid leukemia
SECONDARY OBJECTIVES
I Determine the therapeutic response in patients treated with this regimen II Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to age under age 60 vs age 60 and over Patients are assigned to 1 of 2 strata
Stratum I under age 60 Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 2 hours twice daily on days 2 4 and 6
Stratum II age 60 and over Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 4 hours once daily on days 2-6
In both strata treatment continues in the absence of unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of GTI-2040 and high-dose cytarabine 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
PROJECTED ACCRUAL A total of 6-51patients will be accrued for this study within 2-16 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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 0304 | None | None | None |
| CDR0000334898 | None | None | None |
| OSU-20030030 | None | None | None |
| NCI-6108 | None | None | None |
| OSU-0304 | None | None | None |