Status:
COMPLETED
Phase II 5-Azacytidine Plus VPA Plus ATRA
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief Summary
5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-a...
Detailed Description
Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. In my laboratory, we have developed in vitro models using HL-60 and MOLT4 leukemic cells to study the...
Eligibility Criteria
Inclusion
- Patients with refractory or relapsed: acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) (bone marrow blasts \> or = 10%) are eligible.
- Untreated patients older than 60 years of age with AML or MDS (bone marrow blasts \> or = 10%) who refuse or are not eligible for front-line chemotherapy, are eligible.
- Performance status of \< or = 2 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas M D Anderson Cancer Center (UTMDACC).
- Age \> 2 years. Valproic acid has been associated with a higher rate of severe liver toxicity in children younger than 2 years.
- 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. Use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.
- Adequate liver function (bilirubin of \< 2mg/dL, SGPT \< 3 \* ULN) and renal function (creatinine \< 2mg/dL).
- Women of childbearing potential must practice contraception. Men and women must continue birth control for the duration of the trial.
- Patients with relapsed /refractory disease with inv16, t(8;21) or t(15;17) are eligible.
Exclusion
- Nursing and pregnant females are excluded.
- Patients with active and uncontrolled infections are excluded.
- Patients already receiving valproic acid or receiving other anticonvulsants will be excluded.
- Untreated patients younger than 60 years will not be candidates for this study.
- Patients with untreated disease inv16, t(8;21) or t(15;17) will be excluded.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00326170
Start Date
July 1 2005
End Date
December 1 2007
Last Update
June 15 2012
Active Locations (1)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030