Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 8:36 PM
Study NCT ID:
NCT00052403
Status:
WITHDRAWN
Last Update Posted:
2014-01-16
First Post:
2003-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D000276', 'term': 'Adjuvants, Immunologic'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}], 'ancestors': [{'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not successful at recruiting particpants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2003-01-24', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.\n\nPURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors.\n* Determine the toxic effects of this drug in these patients.\n* Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.\n* Determine the potential anti-tumor activity of this drug in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated as above at that dose level.\n\nPROJECTED ACCRUAL: A total of 27-33 patients will be accrued for this study within 9-11 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nDISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists\n* Measurable or evaluable disease\n* Must have clinical or radiological evidence of disease\n* Disease must be accessible to biopsy and imaging studies\n* No known brain metastases\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 3 months\n\nHematopoietic\n\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* No prior bleeding disorder\n\nHepatic\n\n* Bilirubin no greater than 1.2 mg/dL\n* alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN)\n* Prothrombin time (PT)/ partial thromboplastin time (PTT) no greater than ULN\n\nRenal\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n* Willing to be premedicated for delayed contrast-enhanced MRI\n* No prior claustrophobia\n* No dementia or altered mental status that would preclude informed consent\n* No other uncontrolled concurrent illness\n* No ongoing or active infection\n* No psychiatric illness or social situations that would preclude study compliance\n* No immunodeficiency\n* HIV negative\n* Must be willing to receive blood products\n* No thyroid disease\n* Thyroxine and thyroid-stimulating hormone no greater than ULN\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 4 weeks since prior immunotherapy\n\nExclusion Criteria Chemotherapy\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n* Prior taxanes allowed\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy except:\n* Concurrent hormonal replacement therapy\n* Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy and recovered\n* No prior radiotherapy to more than 25% of the bone marrow\n* No concurrent radiotherapy\n\nSurgery\n\n* More than 4 weeks since prior surgery\n\nOther\n\n* No other concurrent investigational or commercial agents or therapies for the malignancy\n* No other concurrent antitumor therapy'}, 'identificationModule': {'nctId': 'NCT00052403', 'briefTitle': 'Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000258300'}, 'secondaryIdInfos': [{'id': 'WSU-C-2453'}, {'id': 'NCI-5496'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'monoclonal antibody anti-anb3 integrin', 'type': 'DRUG'}, {'name': 'anti-cytokine therapy', 'type': 'PROCEDURE'}, {'name': 'antiangiogenesis therapy', 'type': 'PROCEDURE'}, {'name': 'antibody therapy', 'type': 'PROCEDURE'}, {'name': 'biological response modifier therapy', 'type': 'PROCEDURE'}, {'name': 'growth factor antagonist therapy', 'type': 'PROCEDURE'}, {'name': 'monoclonal antibody therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patricia LoRusso, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Harper Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patricia LoRusso', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}}