Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
18 Years
N/A
Both
Leukemia
Trial Information
Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cytogenetic response (complete and partial)
Safety Issue:
No
Principal Investigator
Istvan Molnar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CCCWFU-23102
NCT ID:
NCT00072579
Start Date:
May 2003
Completion Date:
December 2007
Related Keywords:
- Leukemia
- chronic phase chronic myelogenous leukemia
- chronic myelogenous leukemia, BCR-ABL1 positive
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
| Alamance Cancer Center | Burlington, North Carolina 27216 |
| Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
| Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
| Kentuckiana Cancer Institute, PLLC | Louisville, Kentucky 40202 |
| Hugh Chatham Memorial Hospital | Elkin, North Carolina 28621 |
| Brody School of Medicine at East Carolina University | Greenville, North Carolina 27858 |
