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Study Summary
No. 2006-0943:.......Leukemia......Jorge Cortes......Leukemia
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Study Summary Title
Study Summary
Number:		2006-0943
Study Title:Phase I Study of Gimatecan in Patients with Myelodysplastic Syndromes
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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:713-794-5783
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IReturn
Visit:		Every 4 weeks
Treatment
Agents:		GimatecanHome Care:Gimatecan is orally self-administered.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		No hospitalization anticipated for treatment itself.
Description/
Intervention:		The goal of this clinical research study is to find the highest tolerable dose
of gimatecan that can be given to treat MDS.
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Study Objectives / Outcomes
Primary
To define the maximum tolerated dose and dose limiting toxicity of Gimatecan in patients with myelodysplastic syndromes (MDS).

Secondary
1. To define the efficacy of treatment with Gimatecan in patients with MDS, in terms of complete remission (CR), complete remission with incomplete platelet or neutrophil recovery (CRp and CRn, respectively), partial remission (PR), and hematologic improvement.
    2. To determine the duration of response in patients with MDS treated with Gimatecan.
      3. To determine the survival of patients with MDS treated with Gimatecan.
        4. To determine the quality of life of patients with MDS treated with Gimatecan.
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        Study Status Information
        Study Activation / Registration Date:08/30/2007
        IRB Review and Approval Date:01/26/2007
        Study Type:Phase I
        Recruitment Status:Open
        Projected Accrual:N/A
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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) Patients with MDS with >/= 5% blasts or IPSS risk group intermediate (1 or 2) or high (i.e., IPSS score 0.5 or higher).

        2) Patients must have failed prior therapy with either chemotherapy (e.g., ara-C-based chemotherapy, etc) or biologic agents (e.g., hypomaethylating agents, arsenic, thalidomide, CC5013, farnesyl transferase inhibitors, ATG, cyclosporine, etc).

        3) Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of Gimatecan in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.

        4) ECOG performance status 0-2.

        5) Patients must have normal organ function as defined below: 1) Total bilirubin: </= 1.5 x institutional upper limit of normal; 2) ALT(SGPT): </= 2.5 x institutional upper limit of normal; 3) Creatinine: </= 1.5 x institutional upper limit of normal.

        6) The effects of Gimatecan on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential (ie, not post-menopausal for at least 12 months and not surgically sterile) and men must agree to use double-barrier contraception prior to study entry, for the duration of study participation, and for 3 months following discontinuation of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

        7) Ability to understand and the willingness to sign a written informed consent document.
        Exclusion Criteria:1) Patients who have received only supportive care (transfusions and/or hematopoietic growth factors) for MDS.

        2) Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives of the agent in question (6 weeks for nitrosoureas or mitomycin C), whichever is greater, prior to entering the study or those who have not recovered to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier. The use of hydroxyurea is allowed up to 48 hours prior to the start of therapy with Gimatecan.

        3) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia requiring and not responding to medical intervention, or psychiatric illness/social situations that would limit compliance with study requirements.

        4) Women who are pregnant or breast-feeding.
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        Links
        Registration Number: NCT00493571
        Study Information on Clinical Trials Registry (clinicaltrials.gov)
        Other Links:
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        Results

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