Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360776
Status:
TERMINATED
Last Update Posted:
2017-04-05
First Post:
2006-08-03
Brief Title:
Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte LGL Leukemia
Status:
TERMINATED
Status Verified Date:
2017-04
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 II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia Tipifarnib may stop the growth of leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes needed for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Estimate the complete response rate partial response rate and overall response rate in patients with natural killer NK- or T-cell-large granular lymphocyte LGL leukemia who present with neutropenia or anemia treated with tipifarnib
SECONDARY OBJECTIVES
I Determine the toxicity of tipifarnib in these patients II Determine the mechanism of treatment responses in these patients through correlative laboratory studies
OUTLINE Patients are stratified by disease type natural killer-large granular lymphocyte LGL leukemia vs T-cell-LGL leukemia
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated after completion of course 4 Patients achieving complete response receive 1 additional course of treatment Patients achieving partial response receive 4 additional courses of treatment in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection periodically during study for response mechanism studies and other biomarker correlative studies including mutations of K-ras and N-ras genes
After completion of study treatment patients are followed every 6 months for 5 years
I Estimate the complete response rate partial response rate and overall response rate in patients with natural killer NK- or T-cell-large granular lymphocyte LGL leukemia who present with neutropenia or anemia treated with tipifarnib
SECONDARY OBJECTIVES
I Determine the toxicity of tipifarnib in these patients II Determine the mechanism of treatment responses in these patients through correlative laboratory studies
OUTLINE Patients are stratified by disease type natural killer-large granular lymphocyte LGL leukemia vs T-cell-LGL leukemia
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated after completion of course 4 Patients achieving complete response receive 1 additional course of treatment Patients achieving partial response receive 4 additional courses of treatment in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection periodically during study for response mechanism studies and other biomarker correlative studies including mutations of K-ras and N-ras genes
After completion of study treatment patients are followed every 6 months for 5 years
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |
| 5402 | None | None | None |
| CDR0000489291 | None | None | None |