Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT00060203
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2003-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455279', 'term': 'brostallicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2003-05-06', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Tumor Response Rate', 'timeFrame': '1 year', 'description': '• Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma'}], 'secondaryOutcomes': [{'measure': 'Maximum Tolerated Dose of brostallicin', 'timeFrame': '1 year'}, {'measure': 'Time to response', 'timeFrame': '1 year'}, {'measure': 'Duration of Response', 'timeFrame': '1 year'}, {'measure': 'Time to treatment failure', 'timeFrame': '1 year'}, {'measure': 'Time to tumor progression', 'timeFrame': '1 year'}, {'measure': 'Overall Survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage III multiple myeloma', 'refractory multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma.\n* Determine the maximum tolerated dose of this drug in these patients.\n* Determine the time to and duration of response, time to treatment failure, time to tumor progression, and survival in patients treated with this drug.\n* Determine the safety and tolerability of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n* Correlate baseline whole blood levels and activity of glutathione with clinical outcome in patients treated with this drug.\n\nOUTLINE: This is an open-label, multicenter, dose-escalation study.\n\n* Phase I: Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.\n\n* Phase II: Additional patients are accrued and treated at the MTD of brostallicin as in phase I.\n\nPatients are followed every 2 months.\n\nPROJECTED ACCRUAL: A total of 23-52 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria\\*:\n\n * Major criteria:\n\n * Plasmacytoma on tissue biopsy\n * Bone marrow plasmacytosis with at least 30% plasma cells\n * Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis\n * Minor criteria:\n\n * Bone marrow plasmacytosis with 10% to 30% plasma cells\n * Monoclonal globulin spike present but less than levels in major criterion III above\n * Lytic bone lesions\n * Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: \\*Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d)\n* Measurable disease defined by 1 of the following values:\n\n * Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL\n * Urine M protein (light chain disease) at least 300 mg/24hr\n * Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used)\n* Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy\n* No indolent or smoldering myeloma or localized plasmacytoma\n* No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3 (at least 1,000/mm\\^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells)\n* Platelet count at least 100,000/mm\\^3 (at least 50,000/mm\\^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells)\n* Hemoglobin at least 8.0 g/dL (no transfusion allowed)\n* No hyperviscosity syndrome\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal\n\n* Creatinine no greater than 3.0 times ULN\n* Calcium no greater than 12 mg/dL\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis\n* HIV negative\n* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No AIDS-related illness\n* No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry\n* No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Chemotherapy\n* No concurrent anticancer biological response modifiers\n* No concurrent immunotherapy\n* No concurrent sargramostim (GM-CSF)\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support\n* More than 4 weeks since prior myelosuppressive chemotherapy\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* No concurrent anticancer hormonal therapy\n* No concurrent chronic steroids\n\n * Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks\n* No concurrent corticosteroids (e.g., dexamethasone)\n\nRadiotherapy\n\n* More than 14 days since prior radiotherapy\n* No prior radiotherapy to more than 25% of bone marrow\n* No plans for radiotherapy within the next 6 months\n* Concurrent palliative radiotherapy for skeletal pain allowed\n\nSurgery\n\n* More than 14 days since prior surgery\n* No plans for surgery within the next 6 months\n\nOther\n\n* Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline\n\n * Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2\n* Chronic bisphosphonates for bone pain allowed only for maintenance doses\n* More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy\n* More than 2 weeks since prior macrolide antibiotics\n* No other concurrent investigational agents\n* No concurrent macrolide antibiotics\n* No concurrent participation in another treatment clinical study"}, 'identificationModule': {'nctId': 'NCT00060203', 'briefTitle': 'Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'A Phase I/II Study of the Safety and Efficacy of Brostallicin (PNU-166196A) in Adult Patients With Multiple Myeloma That Has Progressed on Prior Chemotherapy', 'orgStudyIdInfo': {'id': 'PHAR1A02'}, 'secondaryIdInfos': [{'id': 'CWRU-PHAR-1A02'}, {'id': 'PHARMACIA-196-ONC-0100-006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brostallicin', 'interventionNames': ['Drug: brostallicin']}], 'interventions': [{'name': 'brostallicin', 'type': 'DRUG', 'description': 'Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.', 'armGroupLabels': ['Brostallicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Hillard M. Lazarus, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}