RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.
OBJECTIVES: * Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma. * Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen. OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover. Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
high-dose cytarabine IV over 1 hour on days 1-5
high-dose mitoxantrone IV over 15-30 minutes on day 5.
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Event free survival at day 14 (myeloid engraftment)
Time frame: day 14
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment
Time frame: followed for 3 months
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