RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim
may increase the number of immune cells found in bone marrow or peripheral blood and may
help a person's immune system recover from the side effects of chemotherapy. It is not yet
known whether combination chemotherapy is more effective followed by filgrastim or
sargramostim in treating leukemia.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy
followed by filgrastim with that of combination chemotherapy followed by sargramostim in
treating patients who have relapsed or refractory acute myeloid leukemia or acute
- Compare amounts of dendritic cells and leukemia-associated antigen-specific T
lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute
lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after
high-dose cytarabine and mitoxantrone.
OUTLINE: This is a randomized study.
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and
mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts
recover in the absence of unacceptable toxicity.
- Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.
- Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology,
cytochemical staining, and flow cytometry
- In first or subsequent relapse or refractory disease after at least 1 prior treatment
- Antecedent hematologic disorders allowed except Philadelphia chromosome-positive
chronic myelogenous leukemia
- 15 and over
- At least 4 weeks
- Not specified
- Bilirubin no greater than 2 times normal*
- SGOT no greater than 2 times normal* NOTE: *Unless directly attributable to leukemia
- Creatinine no greater than 1.5 times normal* NOTE: *Unless directly attributable to
- Ejection fraction at least 45%* NOTE: *Unless directly attributable to leukemia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent medical or psychiatric illness that would preclude study entry
PRIOR CONCURRENT THERAPY:
- Prior autologous or allogeneic bone marrow or peripheral blood stem cell
- Prior cytokines allowed
- Prior chemotherapy allowed
- No concurrent corticosteroids except for treatment of severe vomiting that is
refractory to standard agents
- Prior radiotherapy allowed
- Not specified