Phase II 5-Azacytidine Plus VPA Plus ATRA

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

July 31, 2007

Study Completion Date

December 31, 2007

Conditions
Myelodysplastic SyndromeAcute Myelogenous Leukemia
Interventions
DRUG

5-Azacytidine (5-aza)

Start at 75 mg/m\^2 subcutaneously daily for 7 days.

DRUG

Valproic Acid

50 mg/kg daily by mouth for 7 days, same days as 5-aza.

DRUG

All-Trans Retinoic Acid (ATRA)

45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.

Trial Locations (1)

77030

The University of Texas M.D. Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER