Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
- Conditions
- Leukemia
- Registration Number
- NCT00072579
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cytogenetic response (complete and partial)
- Secondary Outcome Measures
Name Time Method Survival Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0 Time to progression
Trial Locations
- Locations (15)
Brody School of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Kentuckiana Cancer Institute, PLLC
🇺🇸Louisville, Kentucky, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Alamance Cancer Center
🇺🇸Burlington, North Carolina, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Hugh Chatham Memorial Hospital
🇺🇸Elkin, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas - Eastside
🇺🇸Greenville, South Carolina, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States