RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating
factors such as 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
therapy. Combining sargramostim with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who
are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in
OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and
interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II.
Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these
OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon
entering the study. Once a complete hematologic response is achieved and the interferon alfa
dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily
for 6 months. Patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Cytogenetically or molecularly proven chronic phase chronic
myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome
negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein On
interferon alfa therapy less than 6 months In complete hematologic response, defined as:
WBC less than 10,000/mm3 Platelet count less than 450,000/mm3 Less than 5% circulating
blasts No signs and symptoms of disease, including progressive splenomegaly
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not
specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use
effective contraception No history of intolerance to sargramostim (GM-CSF) Must be able to
perform self injection
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alfa required Chemotherapy:
Prior hydroxyurea and cytarabine allowed Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified Other: No other concurrent myelosuppressive drug