Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101153
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2005-01-07
Brief Title:
Tipifarnib Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Study Of Therapy With The Farnesyl Transferase Inhibitor R115777 Zarnestra Combined With Conventional Induction And Consolidation Chemotherapy For Previously Untreated Patients Over Age 55 With Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2015-07
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 Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving tipifarnib together with cytarabine and daunorubicin may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given with cytarabine and daunorubicin in treating older patients with acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given with cytarabine and daunorubicin in treating older patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of tipifarnib when administered with cytarabine and daunorubicin in older patients with previously untreated acute myeloid leukemia
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of tipifarnib
Induction therapy 1 course Patients receive cytarabine IV continuously on days 1-7 daunorubicin IV on days 6-8 and oral tipifarnib twice daily on days 6-15 in the absence of unacceptable toxicity Patients achieving complete remission proceed to consolidation therapy
Consolidation therapy 1 course After hematologic recovery patients begin consolidation therapy 35-60 days after the start of induction therapy Patients receive cytarabine daunorubicin and tipifarnib as in induction therapy
Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity A total of 10 patients are treated at the recommended phase II dose
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-28 patients will be accrued for this study within 15-22 months
Determine the maximum tolerated dose of tipifarnib when administered with cytarabine and daunorubicin in older patients with previously untreated acute myeloid leukemia
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of tipifarnib
Induction therapy 1 course Patients receive cytarabine IV continuously on days 1-7 daunorubicin IV on days 6-8 and oral tipifarnib twice daily on days 6-15 in the absence of unacceptable toxicity Patients achieving complete remission proceed to consolidation therapy
Consolidation therapy 1 course After hematologic recovery patients begin consolidation therapy 35-60 days after the start of induction therapy Patients receive cytarabine daunorubicin and tipifarnib as in induction therapy
Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity A total of 10 patients are treated at the recommended phase II dose
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-28 patients will be accrued for this study within 15-22 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 |
|---|---|---|---|
| CDR0000405840 | REGISTRY | None | None |
| NCI-6670 | Registry Identifier | PDQ Physician Data Query | None |