STI571 in Treating Patients With Recurrent Leukemia

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia.

PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

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