Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Myelofibrosis/Myeloproliferative Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

October 31, 2007

Conditions
Chronic Myeloproliferative DisordersLeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases
Interventions
DIETARY_SUPPLEMENT

ascorbic acid

The dose of ascorbic acid will be 1000 mg PO 2-3 hours prior to ATO infusion. The treatment will follow the same schedule as arsenic trioxide.

DRUG

arsenic trioxide

Treatment consists of a loading period of five 0.25 mg/kg ATO doses in the first week, followed by maintenance dosing with 0.25 mg/kg ATO twice weekly for 11 weeks. Loading is usually done Monday through Friday of the first treatment week. Maintenance should be started either 72 or 96 hours after the last loading dose. Thereafter, dosing is twice weekly, following an alternating pattern of 72 and 96 hours. For example, maintenance dosing may be done on Mondays and Thursdays, Tuesdays and Fridays, etc. The same pattern should be followed for the entire maintenance dosing period.

DRUG

dexamethasone

Dexamethasone will be given at a dose of 4mg PO daily for five days every four weeks (i.e., days 1-5, 29-33, 57-61, 84-88, etc.).

DRUG

thalidomide

The dose of thalidomide will be 50 mg PO daily starting day 1. The dose will be increased to 100mg PO daily after two weeks if tolerated and only if patients experience \< grade 1 thalidomide-attributed toxicity using CTC criteria.

Trial Locations (2)

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

44106-5065

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT00274820 - Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Myelofibrosis/Myeloproliferative Disorder | Biotech Hunter | Biotech Hunter