Status:
COMPLETED
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodys...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the tolerability of the combination of R115777 (Zarnestra™) and Idarubicin plus cytarabine by defining the DLT and MTD. (Phase I) II. To determine the efficacy of ...
Eligibility Criteria
Inclusion
- Diagnosis of 1) AML (WHO classification definition of \> 20% blasts), or 2) high risk MDS (defined as the presence of \> 10% blasts)
- Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML or MDS; they could have received transfusions, hematopoietic growth factors or vitamins; temporary measures such as pheresis or hydrea (0.5 to 5g daily for up to 3 days) are allowed
- ECOG PS of 0-1 at screening
- Creatinine =\< 2 mg/dl
- Total bilirubin =\< 2 mg/dL, unless increase is due to hemolysis
- Transaminases (SGPT) =\< 2.5 x ULN
- Ability to take oral medication
- Ability to understand and provide signed informed consent
Exclusion
- Subjects with APL
- Presence of active systemic infection
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study
- Known allergy to imidazole drugs (such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, terconazole)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00096122
Start Date
September 1 2004
End Date
February 1 2010
Last Update
May 26 2014
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030