Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

OBJECTIVES:

• Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy.

OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 weeks.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed chronic phase chronic myelogenous leukemia (CML)

• Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow
• Complete hematologic remission during prior therapy* as seen on 2 separate blood count analyses, defined by the following:

• WBC no greater than 10,000/mm^3 AND platelet count no greater than 450,000/mm^3
• Disappearance of all signs and symptoms of disease, including palpable splenomegaly
• Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: *Continuation of therapy that led to complete hematologic remission is required during study participation
• Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day
• Not in complete cytogenetic remission within 30 days of study entry

• Persistent Philadelphia chromosome by bone marrow exam

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No uncontrolled active infective
• No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months
• No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior sargramostim (GM-CSF) allowed
• Prior interferon alfa for CML allowed
• No prior stem cell transplantation
• Concurrent interferon alfa* for CML allowed NOTE: *No dose increase during study participation

Chemotherapy

• At least 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• At least 4 weeks since prior surgery

Other

• Prior imatinib mesylate for CML allowed
• No other concurrent medication for CML
• Concurrent imatinib mesylate* for CML allowed NOTE: *No dose increase during study participation