Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-30 @ 6:47 PM
Study NCT ID:
NCT00045695
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2002-09-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '4 years', 'description': "To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia"}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '4 years', 'description': "To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration."}, {'measure': 'Cytogenetics and genome profiling', 'timeFrame': '4 years', 'description': "To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Waldenstrom macroglobulinemia'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '17353550', 'type': 'RESULT', 'citation': "Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12."}, {'type': 'RESULT', 'citation': "Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004."}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.\n\nPURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.\n* Determine the toxicity of this drug in these patients.\n* Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis\n\n * Newly diagnosed or untreated with IgM ≥ 20 g/L OR\n * Previously treated with IgM ≥ 5 g/L\n* Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)\n* Must have 1 or more of the following:\n\n * Symptomatic lymphadenopathy\n * Hepatomegaly and/or splenomegaly\n * Anemia (i.e., hemoglobin \\< 11.0 g/dL)\n * Hyperviscosity syndrome\n* No other lymphoproliferative disease including transformed aggressive lymphoma\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* See Disease Characteristics\n* Absolute granulocyte count ≥ 1,000/mm\\^3\n* Platelet count ≥ 50,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST or ALT ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nOther\n\n* No uncontrolled bacterial, fungal, or viral infection\n* No pre-existing sensory or motor neurotoxicity grade 2 or greater\n* No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years\n* No other serious illness or medical condition that would preclude study participation\n* No unreasonable geographical limitations\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Chemotherapy\n* See Disease Characteristics\n* At least 12 weeks since prior rituximab (for patients who have progressed)\n* At least 24 weeks since prior rituximab (for patients who have not progressed)\n* No prior high-dose chemotherapy and stem cell transplantation\n* No prior radioactive monoclonal antibodies\n\nChemotherapy\n\n* See Disease Characteristics\n* See Biologic therapy\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\n* No more than 2 prior chemotherapy regimens\n\n * The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens\n * Single-agent rituximab not considered 1 prior regimen\n* No concurrent cytotoxic chemotherapy\n\nEndocrine therapy\n\n* No concurrent corticosteroids\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered\n* No prior radiotherapy to more than 25% of bone marrow\n\nSurgery\n\n* At least 4 weeks since prior major surgery\n\nOther\n\n* At least 4 weeks since prior plasmapheresis\n* At least 4 weeks since prior investigational anticancer therapy\n* No other concurrent investigational anticancer agents or therapies"}, 'identificationModule': {'nctId': 'NCT00045695', 'briefTitle': "Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia", 'orgStudyIdInfo': {'id': 'I152'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND152'}, {'id': 'ECOG-JI152'}, {'id': 'NCI-NCIC-152'}, {'id': 'CDR0000257042', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bortezomib', 'type': 'DRUG', 'description': 'PS-341 bolus intravenous injection twice weekly\\* for 2 out of every 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hinsdale Hematology Oncology Associates', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center at the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Christine I. Chen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}