MDACC Study Summary 2006-0686

Study Summary
No. 2006-0686:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2006-0686

Study Title:	Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) with or without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia

Physician

New Patient Referral



Name:	Hagop Kantarjian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring 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

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Approximately every 4-6 weeks.

Treatment Agents:	Decitabine Valproic Acid	Home 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 find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.

Study Objectives / Outcomes

1.1 Primary:

Compare the response rates to decitabine with or without valproic acid in MDS and AML.

1.2 Secondary: Compare response durations, survivals and side effects of the two regimens. Compare epigenetic modulation (gene expression, hypomethylation, histone acetylation) between the two regimens.

Study Status Information



Study Activation / Registration Date:	12/13/2006

IRB Review and Approval Date:	10/18/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

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 and > 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.

2) Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, GCSF are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.

3) Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT < 2.5x institutional upper limit of normal.

4) Signed informed consent.

Exclusion Criteria:

1) Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

2) Active and uncontrolled infections.

3) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.

4) Known ornithine transcarbamylase disorder.

5) Patients requiring continuous valproic acid treatment for the control of seizure disorders.

Links

Registration Number: NCT00414310
Study Information on Clinical Trials Registry (clinicaltrials.gov)