Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00096122 |
Recruitment Status
:
Completed
First Posted
: November 9, 2004
Results First Posted
: July 15, 2011
Last Update Posted
: May 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) 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 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) Childhood Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Untreated Adult Acute Myeloid Leukemia | Drug: cytarabine Drug: idarubicin Drug: tipifarnib | Phase 1 Phase 2 |
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 the combination of Idarubicin, cytarabine and ZARNESTRA in patients with high-risk MDS and AML. (Phase II)
OUTLINE: This is a dose-escalation study of tipifarnib. Patients are stratified according to age (< 50 versus ≥ 50) and, in patients ≥ 50 years of age, cytogenetics (diploid versus unfavorable).
INDUCTION THERAPY:
PHASE I: Patients receive cytarabine IV continuously on days 1-3 (or 1-4), idarubicin intravenous (IV) over 1 hour on days 1-3, and oral tipifarnib twice daily on days 1-21. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive cytarabine, idarubicin, and tipifarnib as in phase I at the MTD.
Patients in both phases who respond to induction therapy proceed to consolidation maintenance therapy.
CONSOLIDATION MAINTENANCE THERAPY: Patients receive consolidation therapy comprising cytarabine IV continuously on days 1-3, idarubicin IV over 1 hour on days 1-2, and tipifarnib twice daily on days 1-14. Treatment repeats every 4-6 weeks for 5 courses in the absence of unacceptable toxicity.
Patients then begin maintenance therapy comprising oral tipifarnib twice daily on day 1-21. Treatment repeats every 4-6 weeks for 6 courses in the absence of unacceptable toxicity.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PHASE I-II STUDY OF IDARUBICIN, CYTARABINE AND R115777 (TIPIFARNIB, ZARNESTRA; 702818; IND 58359), A FARNESYLTRANSFERASE INHIBITOR, IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROMES AND ACUTE MYELOID LEUKEMIAS |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
See Detailed Description
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Drug: cytarabine
Given IV
Other Names:
Drug: idarubicin
Given IV
Other Names:
Drug: tipifarnib
Given orally
Other Names:
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- Number of Participants With Complete Response [ Time Frame: 21 Day Cycle ]Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.

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Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096122
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jorge Cortes | M.D. Anderson Cancer Center |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096122 History of Changes |
Other Study ID Numbers: |
NCI-2012-02862 2003-0563 6625 N01CM62202 ( U.S. NIH Grant/Contract ) |
First Posted: | November 9, 2004 Key Record Dates |
Results First Posted: | July 15, 2011 |
Last Update Posted: | May 26, 2014 |
Last Verified: | June 2013 |
Additional relevant MeSH terms:
Syndrome Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Anemia Myelodysplastic Syndromes Preleukemia Neoplasm Metastasis Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Anemia, Refractory Anemia, Refractory, with Excess of Blasts Leukemia, Monocytic, Acute Hypereosinophilic Syndrome |
Leukemia, Megakaryoblastic, Acute Leukemia, Erythroblastic, Acute Anemia, Aplastic Leukemia, Basophilic, Acute Leukemia, Eosinophilic, Acute Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Hematologic Diseases Bone Marrow Diseases Precancerous Conditions Neoplastic Processes Myelodysplastic-Myeloproliferative Diseases Eosinophilia |