A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival at day 14 (myeloid engraftment)
Mary J. Laughlin, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|