Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

Decitabine, Arsenic Trioxide and Ascorbic Acid

Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cephalon

INDUSTRY

collaborator

Eisai Inc.

INDUSTRY

lead

Duke University

OTHER