A Phase I Study of STI571 in Ph+ Leukemia

Study start date: January 1, 2002

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