Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124644
Status:
TERMINATED
Last Update Posted:
2013-05-03
First Post:
2005-07-26
Brief Title:
Combination Chemotherapy and Tipifarnib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of R115777 Zarnestra in Combination With Induction Chemotherapy in Patients With Newly Diagnosed High Risk Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to toxicity problems
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 daunorubicin and etoposide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving combination chemotherapy together with tipifarnib may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of tipifarnib when given in combination with induction therapy comprising cytarabine daunorubicin and etoposide followed by consolidation therapy comprising high-dose cytarabine in patients with newly diagnosed high-risk acute myeloid leukemia
Secondary
Determine the qualitative and quantitative toxic effects of this regimen in terms of organ specificity time course predictability and reversibility in these patients
Determine the rate of complete remission in patients treated with this regimen
Determine the remission duration overall survival and relapse-free and event-free survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate pharmacodynamic measurements and levels of tumor necrosis factor-alpha with clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of tipifarnib
Induction therapy Patients receive cytarabine IV continuously on days 1-7 daunorubicin IV and etoposide IV over 2 hours on days 5-7 and oral tipifarnib twice daily on days 5-12
Patients undergo bone marrow biopsy on day 17 OR days 17 and 24 if day 17 bone marrow biopsy shows suspicious disease Patients achieving a complete remission CR proceed to consolidation therapy Patients with residual disease defined as 5 leukemic blasts in a bone marrow of 20 cellularity receive a second course of induction therapy comprising cytarabine IV continuously on days 1-5 daunorubicin IV and etoposide IV over 2 hours on days 4 and 5 and oral tipifarnib twice daily on days 4-9 Patients achieving a CR after a second course of induction therapy proceed to consolidation therapy Patients not achieving a CR after a second course of induction therapy are removed from the study
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 An additional 12 patients are treated at the MTD
Consolidation therapy Patients receive high-dose cytarabine IV twice daily on days 1 3 and 5 Treatment repeats approximately every 6-8 weeks for 4 courses
After completion of study treatment patients are followed every 3-6 months for up to 5 years
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 10-15 months
Primary
Determine the maximum tolerated dose of tipifarnib when given in combination with induction therapy comprising cytarabine daunorubicin and etoposide followed by consolidation therapy comprising high-dose cytarabine in patients with newly diagnosed high-risk acute myeloid leukemia
Secondary
Determine the qualitative and quantitative toxic effects of this regimen in terms of organ specificity time course predictability and reversibility in these patients
Determine the rate of complete remission in patients treated with this regimen
Determine the remission duration overall survival and relapse-free and event-free survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate pharmacodynamic measurements and levels of tumor necrosis factor-alpha with clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of tipifarnib
Induction therapy Patients receive cytarabine IV continuously on days 1-7 daunorubicin IV and etoposide IV over 2 hours on days 5-7 and oral tipifarnib twice daily on days 5-12
Patients undergo bone marrow biopsy on day 17 OR days 17 and 24 if day 17 bone marrow biopsy shows suspicious disease Patients achieving a complete remission CR proceed to consolidation therapy Patients with residual disease defined as 5 leukemic blasts in a bone marrow of 20 cellularity receive a second course of induction therapy comprising cytarabine IV continuously on days 1-5 daunorubicin IV and etoposide IV over 2 hours on days 4 and 5 and oral tipifarnib twice daily on days 4-9 Patients achieving a CR after a second course of induction therapy proceed to consolidation therapy Patients not achieving a CR after a second course of induction therapy are removed from the study
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 An additional 12 patients are treated at the MTD
Consolidation therapy Patients receive high-dose cytarabine IV twice daily on days 1 3 and 5 Treatment repeats approximately every 6-8 weeks for 4 courses
After completion of study treatment patients are followed every 3-6 months for up to 5 years
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 10-15 months
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 |
|---|---|---|---|
| NCI-6623 | None | None | None |
| OSU-05020 | None | None | None |
| OSU-2005C0024 | None | None | None |