A Phase I Study of STI571 in Ph+ Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Recurrent Philadelphia (Ph) chromosome-positive leukemia

- Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR

- Chronic myelogenous leukemia with resistance to interferon alfa with any of the
following:

- WBC at least 20,000/mm^3 after at least 3 months of interferon therapy

- At least 100% increase in WBC to at least 20,000/mm^3 confirmed over 2
weeks while receiving interferon alfa

- At least 66% Ph chromosome-positive cells after 1 year of interferon
therapy

- At least 30% increase in number of Ph chromosome-positive cells after an
interferon-induced response while continuing interferon therapy

PATIENT CHARACTERISTICS:

Age:

- Under 22

Performance status:

- Karnofsky 50-100% if over 10 years of age OR

- Lansky 50-100% if 10 years of age and under

Life expectancy:

- At least 8 weeks

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGPT less than 3 times normal

- Albumin greater than 2 g/dL

Renal:

- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host
disease

- No seizure disorder if on anticonvulsants

- No uncontrolled infection

- No CNS toxicity greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- At least 1 week since prior biologic therapy and recovered

- At least 3 months since prior stem cell transplantation (SCT)

- At least 1 week since prior growth factors

- At least 1 week since prior interferon alfa

Chemotherapy:

- Recovered from prior chemotherapy

- At least 6 weeks since prior busulfan and nitrosoureas

- At least 2 weeks since prior homoharringtonine

- At least 1 week since low-dose cytarabine

- At least 2 weeks since prior moderate-dose cytarabine

- At least 4 weeks since prior high-dose cytarabine

- At least 3 weeks since all other prior cytotoxic chemotherapies

- No prior hydroxyurea

Endocrine therapy:

- Must be on a stable dose of steroids if received prior allogeneic SCT

Radiotherapy:

- Recovered from prior radiotherapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 6 months since prior craniospinal radiotherapy

- At least 6 months since prior radiotherapy to 50% or more of the pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational agents

- No concurrent anticonvulsants