Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-28 @ 11:17 AM
Study NCT ID:
NCT00003561
Status:
TERMINATED
Last Update Posted:
2011-07-20
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'C081222', 'term': 'sargramostim'}], 'ancestors': [{'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-03-19', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['chronic phase chronic myelogenous leukemia', 'Philadelphia chromosome positive chronic myelogenous leukemia', 'Philadelphia chromosome negative chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': "RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Combining sargramostim with interferon alfa may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.", 'detailedDescription': 'OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.\n\nOUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.\n\nPROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Cytogenetically or molecularly proven chronic phase chronic myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein On interferon alfa therapy less than 6 months In complete hematologic response, defined as: WBC less than 10,000/mm3 Platelet count less than 450,000/mm3 Less than 5% circulating blasts No signs and symptoms of disease, including progressive splenomegaly\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No history of intolerance to sargramostim (GM-CSF) Must be able to perform self injection\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alfa required Chemotherapy: Prior hydroxyurea and cytarabine allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent myelosuppressive drug therapy'}, 'identificationModule': {'nctId': 'NCT00003561', 'briefTitle': 'Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CDR0000066625'}, 'secondaryIdInfos': [{'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'JHOC-98011606'}, {'id': 'JHOC-9806'}, {'id': 'NCI-V98-1468'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL'}, {'name': 'sargramostim', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Oncology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Richard J. Jones, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}