Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075010
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2003-12-29
Brief Title:
Phase III Study of Decitabine and Valproic Acid in RelapsedRefractory Leukemia or Myelodysplastic Syndromes
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of 5-aza-2-Deoxycytidine and Valproic Acid in Patients With RelapsedRefractory Leukemia or Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Valproic acid is a medication that is currently used in the prevention of seizures bipolar disorder and migraine headaches Researchers hope that it may improve the effects of decitabine Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes
Detailed Description:
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-2deoxycytidine 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
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-2deoxycytidine 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None