NCT00027872

Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

A Phase II Study of Farnesyl Transferase Inhibitor R115777 (Zarnestra) (R115777 ( Zarnestra), Tipifarnib, R115777, NSC #702818) in Elderly Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
• Adult Acute Basophilic Leukemia
• Adult Acute Eosinophilic Leukemia
• Adult Acute Erythroid Leukemia (M6)
• Adult Acute Megakaryoblastic Leukemia (M7)
• Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
• Adult Acute Monoblastic Leukemia (M5a)
• Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5)
• Adult Acute Monocytic Leukemia (M5b)
• Adult Acute Myeloblastic Leukemia With Maturation (M2)
• Adult Acute Myeloblastic Leukemia Without Maturation (M1)
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Adult Acute Myelomonocytic Leukemia (M4)
• Adult Erythroleukemia (M6a)
• Adult Pure Erythroid Leukemia (M6b)
• Cellular Diagnosis, Adult Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	tipifarnib	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-10-01
• Primary completion: 2007-07-01
• Completion: 2009-01-01
• First posted: 2003-01-27
• Last updated: 2013-03-25

Locations

1 site across 1 country: United States