Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

• Status: Terminated
• Trial end date: 2006-08-11
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Arsenic Trioxide; Azacitidine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia

• International Prognostic Scoring System (IPSS) score ≥ intermediate-1

• Low IPSS score allowed provided patient meets ≥ 1 of the following criteria:

• Platelet count ≤ 50,000/mm^3

• Required platelet or packed red cell transfusions within the past 4 weeks

• Neutropenic (i.e., absolute neutrophil count < 1,000/mm^3) AND has infections requiring antibiotic treatment

• No prior leukemia or refractory anemia with excess blasts in transformation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Baseline QTc < 500 msec

• QTc interval < 460 msec with potassium > 4.0 mEq/L and magnesium > 1.8 mg/L

Immunologic

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs

• No ongoing or active infection

• HIV negative

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

• No other malignancy within the past 12 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior administration of any of the following:

• Interferon

• Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines

• Thalidomide or thalidomide analogs

• No concurrent epoetin alfa

Chemotherapy

• More than 4 weeks since prior chemotherapy

• No prior arsenic trioxide or azacitidine

• No other concurrent chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

• No concurrent androgenic steroids

• Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since prior retinoids

• No other concurrent investigational agents

• No other concurrent anticancer therapy