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Study Summary
No. 2003-0563:.......Leukemia......Jorge Cortes......Leukemia
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Study Summary Title
Study Summary
Number:		2003-0563
Study 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
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Physician New Patient Referral
Name:Jorge CortesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7026
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:		Every 2-3 courses
Treatment
Agents:		Ara-C
Idarubicin
Zarnestra		Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		First course (1 month), then 1 day every 2-3 months
Description/
Intervention:		The goal of this clinical research study is to find the highest safe dose of
the combination of idarubicin, ara-C, and ZARNESTRA (R115777) for the treatment
of patients with AML and high-risk MDS. Once the highest safe dose is found,
researchers will learn if this combination can help control the disease in
newly diagnosed patients with AML and high-risk MDS. The safety of this
treatment will also be studied.
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Study Objectives / Outcomes
1.0 Phase I portion: Determine the tolerability of the combination of R115777 (ZarnestraÔ) and Idarubicin plus cytarabine by defining the DLT and MTD.
    2.0 Phase II portion: Determine the efficacy of the combination of Idarubicin, cytarabine and ZARNESTRA in patients with high-risk MDS and AML.
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    Study Status Information
    Study Activation / Registration Date:09/16/2004
    IRB Review and Approval Date:08/06/2003
    Study Type:Therapeutic
    Recruitment Status:Terminated
    Projected Accrual:96
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Age 15 to 70 years

    2) Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea). They could have received transfusions, hematopoietic growth factors, or vitamins. The study will open to all newly diagnosed patients with AML or high risk MDS or CMML (>/= 10% blasts).

    3) ECOG PS 0-1; Cr </= 2 mg/dl; Bil </= 2 mg/dl; SGPT </= 2.5 x ULN;

    4) Ability to take oral medication and to consent
    Exclusion Criteria:1) Subject with APL

    2) Presence of active systemic infection.

    3) Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.

    4) 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.

    5) Known allergy to imidazole drugs.
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    Links
    Registration Number: NCT00096122
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center