Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383474
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2006-09-29
Brief Title:
Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose-Escalation Study of R115777 Tipifarnib Plus PS-341 Bortezomib in Relapsed or Refractory Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2013-04
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 bortezomib in treating patients with acute leukemia or chronic myelogenous leukemia in blast phase Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving tipifarnib together with bortezomib may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVE
I Determine the dose-limiting toxicity and maximum tolerated dose of tipifarnib and bortezomib in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia or chronic myeloid leukemia in blast phase
SECONDARY OBJECTIVES
I Determine the effect of this regimen on farnesyltransferase and proteasome inhibition in peripheral blood mononuclear cells in these patients
II Determine the clinical efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and oral tipifarnib twice daily on days 1-14 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with partial response or stable disease may continue therapy beyond 6 courses at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of bortezomib and 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
Blood is collected periodically for protein expression studies Bone marrow aspirates obtained at baseline are examined by immunohistochemistry for Ki-67 activity
I Determine the dose-limiting toxicity and maximum tolerated dose of tipifarnib and bortezomib in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia or chronic myeloid leukemia in blast phase
SECONDARY OBJECTIVES
I Determine the effect of this regimen on farnesyltransferase and proteasome inhibition in peripheral blood mononuclear cells in these patients
II Determine the clinical efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and oral tipifarnib twice daily on days 1-14 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with partial response or stable disease may continue therapy beyond 6 courses at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of bortezomib and 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
Blood is collected periodically for protein expression studies Bone marrow aspirates obtained at baseline are examined by immunohistochemistry for Ki-67 activity
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 |
|---|---|---|---|
| P30CA076292 | NIH | CTEP | httpsreporternihgovquickSearchP30CA076292 |
| NCI-2009-00147 | REGISTRY | None | None |
| CDR0000502258 | None | None | None |
| MCC-14796 | OTHER | None | None |
| 7306 | OTHER | None | None |
| N01CM62208 | NIH | None | None |