Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00075010|
Recruitment Status : Completed
First Posted : December 31, 2003
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: Decitabine Drug: Valproic acid||Phase 1 Phase 2|
Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. It has been shown that both DNA methylation and histone deacetylation work together in affecting gene expression.
Therefore, drugs that inhibit DNA methylation and those that inhibit histone deacetylase can reactivate silenced genes in combination better than they can individually. Decitabine (5 aza-2'deoxycytidine), a drug that produces marked DNA hypomethylator, has demonstrated antileukemic activity at low doses. There are several drugs that have been shown to have histone acetylase activity. One of these is valproic acid that has been used safely for many years as an anti-seizure medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of 5-aza-2'-Deoxycytidine and Valproic Acid in Patients With Relapsed/Refractory Leukemia or Myelodysplastic Syndromes|
|Actual Study Start Date :||January 23, 2004|
|Actual Primary Completion Date :||November 8, 2006|
|Actual Study Completion Date :||November 8, 2006|
Experimental: Decitabine + Valproic acid
Decitabine 15 mg/m^2 by vein over 1 hour times 10 days
15 mg/m^2 by vein over 1 hour times 10 days
Other Name: Dacogen®
Drug: Valproic acid
20 mg/kg given orally daily for 10 days
- Maximum Tolerated Dose (MTD) of Valproic Acid + Decitabine [ Time Frame: Up to 8 weeks of therapy ]MTD is the dose level at which less than two participants develop a dose limiting toxicity (DLT). Response evaluated after completing first cycle, 4-8 weeks of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075010
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, M.D.||M.D. Anderson Cancer Center|