Myeloproliferative Neoplasms Clinical Trial
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Summary
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia.
PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
Full Description
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.
Eligibility Criteria
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
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There are 15 Locations for this study
Phoenix Arizona, 85006, United States
Oakland California, 94609, United States
Miami Beach Florida, 33140, United States
Rome Georgia, 30165, United States
Decatur Illinois, 62526, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Burlington North Carolina, 27216, United States
Elkin North Carolina, 28621, United States
Goldsboro North Carolina, 27534, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43206, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
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