Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096122
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2004-11-09
Brief Title:
Idarubicin Cytarabine and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I-II STUDY OF IDARUBICIN CYTARABINE AND R115777 TIPIFARNIB ZARNESTRA 702818 IND 58359 A FARNESYLTRANSFERASE INHIBITOR IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROMES AND ACUTE MYELOID LEUKEMIAS
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 III trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia Drugs used in chemotherapy such as idarubicin and cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die Tipifarnib Zarnestra may stop the growth of cancer cells by blocking the enzymes necessary for their growth Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the tolerability of the combination of R115777 Zarnestra and Idarubicin plus cytarabine by defining the DLT and MTD Phase I II To determine the efficacy of the combination of Idarubicin cytarabine and ZARNESTRA in patients with high-risk MDS and AML Phase II
OUTLINE This is a dose-escalation study of tipifarnib Patients are stratified according to age 50 versus 50 and in patients 50 years of age cytogenetics diploid versus unfavorable
INDUCTION THERAPY
PHASE I Patients receive cytarabine IV continuously on days 1-3 or 1-4 idarubicin intravenous IV over 1 hour on days 1-3 and oral tipifarnib twice daily on days 1-21 Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of tipifarnib 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
PHASE II Patients receive cytarabine idarubicin and tipifarnib as in phase I at the MTD
Patients in both phases who respond to induction therapy proceed to consolidation maintenance therapy
CONSOLIDATION MAINTENANCE THERAPY Patients receive consolidation therapy comprising cytarabine IV continuously on days 1-3 idarubicin IV over 1 hour on days 1-2 and tipifarnib twice daily on days 1-14 Treatment repeats every 4-6 weeks for 5 courses in the absence of unacceptable toxicity
Patients then begin maintenance therapy comprising oral tipifarnib twice daily on day 1-21 Treatment repeats every 4-6 weeks for 6 courses in the absence of unacceptable toxicity
I To determine the tolerability of the combination of R115777 Zarnestra and Idarubicin plus cytarabine by defining the DLT and MTD Phase I II To determine the efficacy of the combination of Idarubicin cytarabine and ZARNESTRA in patients with high-risk MDS and AML Phase II
OUTLINE This is a dose-escalation study of tipifarnib Patients are stratified according to age 50 versus 50 and in patients 50 years of age cytogenetics diploid versus unfavorable
INDUCTION THERAPY
PHASE I Patients receive cytarabine IV continuously on days 1-3 or 1-4 idarubicin intravenous IV over 1 hour on days 1-3 and oral tipifarnib twice daily on days 1-21 Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of tipifarnib 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
PHASE II Patients receive cytarabine idarubicin and tipifarnib as in phase I at the MTD
Patients in both phases who respond to induction therapy proceed to consolidation maintenance therapy
CONSOLIDATION MAINTENANCE THERAPY Patients receive consolidation therapy comprising cytarabine IV continuously on days 1-3 idarubicin IV over 1 hour on days 1-2 and tipifarnib twice daily on days 1-14 Treatment repeats every 4-6 weeks for 5 courses in the absence of unacceptable toxicity
Patients then begin maintenance therapy comprising oral tipifarnib twice daily on day 1-21 Treatment repeats every 4-6 weeks for 6 courses in the absence of unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62202 | NIH | None | httpsreporternihgovquickSearchN01CM62202 |
| 2003-0563 | None | None | None |
| 6625 | None | None | None |