Combination Chemotherapy and Tipifarnib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with tipifarnib may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin; Enzyme Inhibitors; Etoposide; Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed acute myeloid leukemia (AML) according to the WHO classification system

• High-risk disease

• Newly diagnosed disease

• Patients with secondary AML due to prior chemotherapy for a different malignancy are eligible

• No known inv(16), t(8;21), or t(15;17) cytogenetic abnormality

• No acute promyelocytic leukemia

• No CNS leukemia

PATIENT CHARACTERISTICS:

Age

• 18 to 59

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Not specified

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal

• Bilirubin normal

Renal

• Creatinine normal OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• Ejection fraction > 50% by echocardiogram or MUGA

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Immunologic

• No known HIV positivity

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib

• No allergy to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole)

• No ongoing or active infection

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent epoetin alfa

Chemotherapy

• See Disease Characteristics

• No prior chemotherapy for AML or myelodysplastic syndromes except hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent palliative radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior investigational agents

• No other concurrent investigational or commercial agents or therapies for the malignancy