Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

OBJECTIVES:

• 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 treatment arms.

• 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.

DISEASE CHARACTERISTICS:

• 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 regimen
• Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

Age

• 15 and over

Performance status

• 0-3

Life expectancy

• At least 4 weeks

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2 times normal*
• SGOT no greater than 2 times normal* NOTE: *Unless directly attributable to leukemia

Renal

• Creatinine no greater than 1.5 times normal* NOTE: *Unless directly attributable to leukemia

Cardiovascular

• Ejection fraction at least 45%* NOTE: *Unless directly attributable to leukemia

Other

• 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:

Biologic therapy

• Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed
• Prior cytokines allowed

Chemotherapy

• Prior chemotherapy allowed

Endocrine therapy

• No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents

Radiotherapy

• Prior radiotherapy allowed

Surgery

• Not specified