Status:
TERMINATED
Combination Chemotherapy and Tipifarnib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of tipifarnib when given in combination with induction therapy comprising cytarabine, daunorubicin, and etoposide followed by consolidation...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00124644
Start Date
March 1 2006
End Date
January 1 2008
Last Update
May 3 2013
Active Locations (1)
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1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240