Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT00059995
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510955', 'term': 'iratumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2003-05-06', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent adult Hodgkin lymphoma', 'recurrent/refractory childhood Hodgkin lymphoma', 'anaplastic large cell lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent childhood large cell lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '17515574', 'type': 'RESULT', 'citation': "Ansell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, Keler T, Graziano R, Blanset D, Yellin M, Fischkoff S, Assad A, Borchmann P. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol. 2007 Jul 1;25(19):2764-9. doi: 10.1200/JCO.2006.07.8972. Epub 2007 May 21."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.\n* Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.\n* Determine the pharmacokinetic profile of this drug in these patients.\n* Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter, dose-escalation study.\n\nPatients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.\n\nCohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.\n\nPatients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.\n\nPROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed B-cell or T-cell lymphoma\n\n * Hodgkin's lymphoma and anaplastic large cell lymphoma eligible\n * No HIV-associated lymphoma\n* CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry\n\n * At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30\n* Must meet one of the following criteria for relapsed/refractory disease:\n\n * Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)\n\n * Relapsed disease must be within the prior irradiated field\n * Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option\n\n * Disease progression must be within the prior irradiated field\n* Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 12\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* WBC at least 1,500/mm\\^3\\*\n* Neutrophil count at least 1,000/mm\\^3\\*\n* Platelet count at least 75,000/mm\\^3\\*\n* Hemoglobin at least 8.0 g/dL\\* NOTE: \\*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed\n\nHepatic\n\n* AST no greater than 2 times upper limit of normal (ULN)\\*\n* Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)\\*\n* Hepatitis B surface antigen negative\n* Hepatitis C antibody negative NOTE: \\*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed\n\nRenal\n\n* Creatinine no greater than 2 times ULN\\* NOTE: \\*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception during and for 9 months after study participation\n* HIV negative\n* No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No active significant infection\n* No apparent opportunistic infection, as indicated by any of the following:\n\n * Purified protein derivative recently determined to be positive\n * Infectious infiltrate by chest x-ray\n * Recent changes in fever/chill patterns\n * New, unexplained neurological symptoms\n* No underlying medical condition that would preclude receiving study therapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* No prior anti-CD30 antibody therapy\n* No other concurrent biologic therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent systemic steroidal therapy (excluding physiologic doses)\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent investigational agents"}, 'identificationModule': {'nctId': 'NCT00059995', 'briefTitle': 'MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma', 'orgStudyIdInfo': {'id': 'MDX-060-01'}, 'secondaryIdInfos': [{'id': 'MSKCC-02121'}, {'id': 'CDR0000298995', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'iratumumab', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Steven M. Horwitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}