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

NCT ID: NCT00072579

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2007-12-31

Brief 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.

Detailed 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.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Istvan Molnar, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Bayard L. Powell, MD

Role:

Wake Forest University Health Sciences

Locations

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

CCOP - Bay Area Tumor Institute

Oakland, California, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Regional Radiation Oncology Center at Rome

Rome, Georgia, United States

CCOP - Central Illinois

Decatur, Illinois, United States

Kentuckiana Cancer Institute, PLLC

Louisville, Kentucky, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Alamance Cancer Center

Burlington, North Carolina, United States

Hugh Chatham Memorial Hospital

Elkin, North Carolina, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

CCOP - Columbus

Columbus, Ohio, United States

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

CDR0000340983

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRLX-02153

Identifier Type: -

Identifier Source: secondary_id

NCI-7350

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-23102

Identifier Type: -

Identifier Source: org_study_id