Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 (ZARNESTRA, Tipifarnib, NSC #702818, IND #58,359) in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia (AML)
This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in treating older patients with newly diagnosed acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells
PRIMARY OBJECTIVES:
I. To determine the feasibility, tolerability, and toxicities of administering a fixed dose
of R115777 in combination with escalating doses of VP-16 in elderly adults ( = 70 years)
with newly diagnosed, previously untreated acute myelogenous leukemia (AML).
II. To determine the maximal tolerated dose (MTD) of R115777 + VP-16 combination, including
the duration of R115777 administration, for future Phase II trials.
III. To obtain preliminary descriptive data regarding the effects of R115777 + VP-16 on cell
cycle progression and apoptosis in AML marrow cells.
IV. To study mechanisms of leukemia cell resistance to R115777 in combination with
etoposide.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral tipifarnib twice daily on days 1-14 OR 1-21 and oral etoposide once
daily on days 1-3 and 8-10. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity. Patients who achieve a complete response (CR) may
receive up to 5 additional courses of therapy beyond documentation of CR.
Cohorts of 3-6 patients receive escalating doses of tipifarnib and etoposide 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. Up to 14 additional
patients receive treatment at the MTD.
After completion of study treatment, patients are followed at 1 month and then every 3
months thereafter.
PROJECTED ACCRUAL: A total of 3-100 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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