Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

December 31, 2008

Study Completion Date

November 30, 2010

Conditions
LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

arsenic trioxide

Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).

DRUG

gemtuzumab ozogamicin

Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion

Trial Locations (1)

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

All Listed Sponsors
collaborator

University of Michigan

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

The Cleveland Clinic

OTHER

NCT00274781 - Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter