Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112853
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2005-06-02
Brief Title:
Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 ZARNESTRA Tipifarnib NSC 702818 IND 58359 in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia AML
Status:
COMPLETED
Status Verified Date:
2013-01
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 tipifarnib and etoposide in treating older patients with newly diagnosed acute myeloid leukemia Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as etoposide 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 etoposide may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the feasibility tolerability and toxicities of administering a fixed dose of R115777 in combination with escalating doses of VP-16 in elderly adults 70 years with newly diagnosed previously untreated acute myelogenous leukemia AML
II To determine the maximal tolerated dose MTD of R115777 VP-16 combination including the duration of R115777 administration for future Phase II trials
III To obtain preliminary descriptive data regarding the effects of R115777 VP-16 on cell cycle progression and apoptosis in AML marrow cells
IV To study mechanisms of leukemia cell resistance to R115777 in combination with etoposide
OUTLINE This is a multicenter dose-escalation study
Patients receive oral tipifarnib twice daily on days 1-14 OR 1-21 and oral etoposide once daily on days 1-3 and 8-10 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR may receive up to 5 additional courses of therapy beyond documentation of CR
Cohorts of 3-6 patients receive escalating doses of tipifarnib and etoposide 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 Up to 14 additional patients receive treatment at the MTD
After completion of study treatment patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-100 patients will be accrued for this study
I To determine the feasibility tolerability and toxicities of administering a fixed dose of R115777 in combination with escalating doses of VP-16 in elderly adults 70 years with newly diagnosed previously untreated acute myelogenous leukemia AML
II To determine the maximal tolerated dose MTD of R115777 VP-16 combination including the duration of R115777 administration for future Phase II trials
III To obtain preliminary descriptive data regarding the effects of R115777 VP-16 on cell cycle progression and apoptosis in AML marrow cells
IV To study mechanisms of leukemia cell resistance to R115777 in combination with etoposide
OUTLINE This is a multicenter dose-escalation study
Patients receive oral tipifarnib twice daily on days 1-14 OR 1-21 and oral etoposide once daily on days 1-3 and 8-10 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR may receive up to 5 additional courses of therapy beyond documentation of CR
Cohorts of 3-6 patients receive escalating doses of tipifarnib and etoposide 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 Up to 14 additional patients receive treatment at the MTD
After completion of study treatment patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-100 patients will be accrued for this study
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 |
|---|---|---|---|
| U01CA070095 | NIH | None | httpsreporternihgovquickSearchU01CA070095 |
| J04110 | None | None | None |
| N01CM62204 | NIH | None | None |