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Home > "S" Clinical Trials Conditions > Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment  Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of sargramostim in treating patients who have chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
Details: 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. Treatment continues 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BayardPowell, , Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Istvan Molnar 336-716-5847
Additional Information:
Study ID Numbers: CDR0000340983; BRLX-02153,CCCWFU-23102
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072579
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
2. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
3. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
4. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
5. Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
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