Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, AIDS-related Peripheral/Systemic Lymphoma
About this trial
This is an interventional treatment trial for Accelerated Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective All tumor types are eligible, including: Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR Gastrointestinal stromal tumors Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month No unstable or untreated (non-irradiated) brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No active hemolysis See Surgery No evidence of biliary sepsis Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Able to swallow pills No other uncontrolled concurrent illness that would preclude study participation No ongoing or active infection No uncontrolled diarrhea No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 6 months after study completion At least 24 hours since prior colony-stimulating factors No concurrent colony-stimulating factors At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered See Disease Characteristics See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered See Disease Characteristics At least 10 days since prior placement of shunt for treatment of biliary obstruction At least 14 days since prior major surgery No prior solid organ transplantation No other concurrent investigational agents No concurrent therapeutic doses of warfarin for anticoagulation No other concurrent investigational or commercial agents or therapies for treatment of this disease No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent acetaminophen of more than 4,000 mg/day
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Experimental
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity