Status:
COMPLETED
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 hav...
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 compl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072579
Start Date
May 1 2003
End Date
December 1 2007
Last Update
January 19 2017
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
2
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
3
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
4
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165