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Study Summary
No. 2005-0895:.......Leukemia......Guillermo Garcia-Manero......Leukemia
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Study Summary Title
Study Summary
Number:		2005-0895
Study Title:PHASE I STUDY OF LOW DOSE 5-AZA-2'-DEOXYCYTIDINE ADMINISTERED DAILY FOR 5 DAYS EVERY OTHER WEEK FOR PATIENTS WITH RELAPSED OR REFRACTORY ACUTE LYMPHOCYTIC LEUKEMIA.
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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:N/A
Phase of Study:Phase IReturn
Visit:		Once a week during first course and then every other week.
Treatment
Agents:		DecitabineHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to check the safety and
tolerability of decitabine in patients with ALL. Any evidence of activity with
this drug will also be studied.
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Study Objectives / Outcomes
      1-To determine the safety and tolerability of 5-aza-2'-deoxycytidine (decitabine) administered daily for 5 days every other week in patients with relapsed or refractory acute lymphocytic leukemia (ALL).

      2-To determine the clinical activity of this schedule of decitabine in this patient population.

      3-To determine the safety and tolerability of decitabine in combination with hyperCVAD based chemotherapy in patients with relapsed or refractory ALL.

      4-To determine the clinical activity of this schedule of decitabine in combination with hyperCVAD in this patient population.
5-To determine the effects of decitabine administration on DNA methylation and gene expression in this patient population.
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Study Status Information
Study Activation / Registration Date:07/03/2006
IRB Review and Approval Date:02/01/2006
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 refractory or relapsed acute lymphocytic leukemia (ALL).

2) Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.

3) Patients of any age are eligible.

4) Patients must have been off chemotherapy for 1 week prior to entering this study and recovered from the toxic effects (< grade 2) of that therapy, unless there is evidence of rapidly progressive disease. Use of high dose steroids with dexamethasone is allowed during the first 2 courses of therapy. Imatinib mesylate (Gleevec) must be stopped 1 week prior to entering this study.

5) Adequate liver function (bilirubin of < 3 mg/dL, SGPT < 5 x ULN) and renal function (creatinine < 3mg/dL) unless proven to be related to disease infiltration.

6) Women of childbearing potential must practice contraception. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. Men and women must continue birth control for the duration of the trial.
Exclusion Criteria:1) Nursing and pregnant females are excluded.
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Links
Registration Number: NCT00349596
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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