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.

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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.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Study ID:

NCT00072579

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There are 15 Locations for this study

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CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Regional Radiation Oncology Center at Rome
Rome Georgia, 30165, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Kentuckiana Cancer Institute, PLLC
Louisville Kentucky, 40202, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Alamance Cancer Center
Burlington North Carolina, 27216, United States
Hugh Chatham Memorial Hospital
Elkin North Carolina, 28621, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Brody School of Medicine at East Carolina University
Greenville North Carolina, 27858, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Cancer Centers of the Carolinas - Eastside
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Study ID:

NCT00072579

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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