A Phase 2 interventional study of tipifarnib and laboratory biomarker analysis in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Basophilic Leukemia and Adult Acute Eosinophilic Leukemia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-03-25.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia
PRIMARY OBJECTIVES:
I. To determine the complete response rate of R115777 (tipifarnib) in previously untreated acute myeloid leukemia (AML) in (a) elderly patients (age >= 75) and (b) patients (age >= 65) with AML preceded by myelodysplastic syndrome (MDS), using a chronic dosing schedule.
SECONDARY OBJECTIVES:
I. To determine progression-free and overall survival in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.
II. To determine the duration of response in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.
III. To determine the effect of R115777 on the phosphorylation of mitogen-activated protein kinase (MAPK) and phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K) in leukemic cells.
IV. To determine the effect of R115777 on processing of the farnesylated protein HDJ-2.
V. To determine the toxicities of R115777 when given in a chronic dosing schedule.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 11-17 months.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 125 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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AML (any of the following):
Exclusion Criteria:
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
Drug: tipifarnib · Other: laboratory biomarker analysis
Given orally
Also known as: R115777, Zarnestra
Correlative studies
Complete remission (CR) rate
CR rates will be calculated with 95% confidence intervals for each age group separately.
Time frame: Up to 8 years
Partial remission (PR) rate
Will be estimated by observed proportions and 95% confidence intervals.
Time frame: Up to 8 years
Toxicity rates assessed using NCI CTCAE version 3.0
Will be estimated by observed proportions and 95% confidence intervals.
Time frame: Up to 8 years
Duration of response
Duration of response and survival will be summarized by the Kaplan-Meier estimate of the survival distribution.
Time frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 8 years
Duration of survival
Duration of response and survival will be summarized by the Kaplan-Meier estimate of the survival distribution.
Time frame: From time of enrollment onto this study to the time of death, assessed up to 8 years
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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