Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT00101296|
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : February 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome 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) Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia||Drug: tipifarnib Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
I. To define the maximum tolerated dose (MTD) of R115777 (tipifarnib) in patients with relapsed, refractory, or high risk myeloid leukemias treated according to this regimen.
II. To assess the toxicity and preliminary assessment of efficacy of R115777 in patients with relapsed, refractory, or high risk myeloid leukemias.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients experiencing relapse after previously achieving CR may receive additional tipifarnib at the current dose level for newly registered patients.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the 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.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of R115777 (NSC 702818) in Relapsed, Refractory or High Risk Myeloid Leukemia|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||May 2011|
Experimental: Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients achieving a CR receive 2 additional courses beyond CR. Patients experiencing relapse after previously achieving CR may receive additional tipifarnib at the current dose level for newly registered patients.
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- MTD defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing dose limiting toxicity (DLT) assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 28 days ]The toxicities observed at each dose level will be summarized in terms of type, severity, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
- Objective tumor response [ Time Frame: Up to 6.5 years ]Will be summarized at each dose level, and the number and percent responding combined across dose levels.
- Survival [ Time Frame: From registration to time of death due to any cause, assessed up to 6.5 years ]Will be summarized with Kaplan-Meier plots.
- Time to treatment failure [ Time Frame: From registration to the first observation of disease progression, death due to any cause, or early discontinuation of treatment, assessed up to 6.5 years ]Will be summarized with Kaplan-Meier plots.
- Duration of response [ Time Frame: Up to 6.5 years ]Will be summarized with Kaplan-Meier plots.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101296
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Mark Kirschbaum||City of Hope Medical Center|