Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
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.
|Leukemia Lymphoma||Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies|
- 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 ]
|Study Start Date:||November 2001|
|Study Completion Date:||September 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047021
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-7284|
|Principal Investigator:||Mary J. Laughlin, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|