A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous
leukemia, meeting one of the following criteria:

- Chronic phase

- Less than 15% blasts in peripheral blood or marrow

- Less than 30% blasts and promyelocytes in peripheral blood or marrow

- Less than 20% basophils in blood or marrow

- Platelet count at least 100,000/mm^3 (unless therapy related)

- No progressive (increase of at least 10 cm in any 4 of the past 24 weeks)
or existing (greater than 10 cm) splenomegaly

- Complete hematologic response (CHR)

- No immature myeloid cells in peripheral blood

- No increased basophils in peripheral blood

- WBC less than upper limit of normal (ULN)

- Platelet count less than ULN

- No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response
after at least 6 months of imatinib mesylate

- Loss of prior major cytogenetic response or failure to achieve major
cytogenetic response

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin less than 1.5 times ULN

- AST or ALT less than 2.5 times ULN

Renal

- Creatinine less than 1.5 times ULN

Cardiovascular

- No New York Heart Association grade III or IV congestive heart failure

- No untreated symptomatic cardiac ischemia

- No underlying cardiac arrhythmia, including but not limited to any of the following:

- Conduction abnormality/atrioventricular heart block

- Nodal/junctional arrhythmia/dysrhythmia

- Sinus bradycardia or tachycardia

- Supraventricular tachycardia

- Ventricular arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 methods of effective barrier contraception during and for
3 months after study

- Electrolyte levels (especially potassium and magnesium) normal (CHR patients)

- No history of noncompliance that would preclude study participation

- No other concurrent serious, uncontrolled medical condition

- No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride,
or imatinib mesylate

- More than 28 days since prior investigational agents

- No concurrent grapefruit or grapefruit juice