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Study Summary
No. 2007-0883:.......Leukemia......Guillermo Garcia-Manero......Leukemia
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Study Summary Title
Study Summary
Number:		2007-0883
Study Title:Randomized Open-Label Phase 2 Study of Low Dose DACOGEN® (Decitabine) for Injection in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes
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Physician New Patient Referral
Name:Guillermo Garcia-ManeroPatients 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:713-745-3428
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:MGI PHARMA, INC.
Phase of Study:Phase IIReturn
Visit:		Weekly for the first month, then monthly.
Treatment
Agents:		DecitabineHome Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to learn about the safety and level
of effectiveness of 2 different dose schedules of Dacogen® (decitabine) for
Injection when given by injection under the skin to patients with MDS.
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Study Objectives / Outcomes
The Primary Objective of this study is to determine the clinical activity (overall improvement rate), safety, and tolerability of two different low-dose schedules of Dacogen ® for Injection (called decitabine throughout the rest of this protocol) in patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS).

The secondary objectives of this study are to assess:

· Hematologic improvement (HI)
· Transfusion requirements
· Cytogenetic response
· Toxicity
· Overall survival

Tertiary Objective: The optional tertiary objective is to assess the molecular effects of decitabine administration using these dosing schedules in this patient population by using DNA methylation and gene expression assays.
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Study Status Information
Study Activation / Registration Date:09/10/2008
IRB Review and Approval Date:09/10/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:80
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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) Male or female patients age 18 years and older;

2) Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment;

3) Must have ECOG performance status of 0-2;

4) Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total bilirubin of < 2 times upper limit of normal, and AST and ALT </= 2 times upper limit of normal) unless proven to be related to disease infiltration.

5) Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized);

6) Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study;

7) Patients with low or intermediate-1 risk MDS by the IPSS classification.
Exclusion Criteria:1) Women who are pregnant or nursing;

2) Those who have received prior therapy with decitabine;

3) Prior therapy with azacitidine (Vidaza®);

4) Those who received growth factor support or lenalidomide in the 30 days prior the first dose of decitabine;

5) Patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the Investigator and after discussion with the Sponsor and Primary Investigator, would make the patient inappropriate for study entry.
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Links
Registration Number: NCT00619099
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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