Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

Weill Cornell Medicine (WCM)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myelodysplastic Syndrome

Treatments

Drug: Cytarabine

Drug: Arsenic Trioxide (Tricenox)

Study type

Interventional

Funder types

Other

Identifiers

NCT00195104

0603-887

Details and patient eligibility

About

The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

Full description

This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.

Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologic diagnosis of high-risk MDS (IPSS int-2).
No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).

Exclusion criteria

Pregnant or lactating women.
Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range.
Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
Uncontrolled or severe cardiovascular or pulmonary disease.