Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT00024232
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2001-09-13', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV prostate cancer', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, '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 II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer.\n* Determine the biodistribution and dosimetry of this antibody in these patients.\n* Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients.\n* Determine the HAHA response in patients treated with this regimen.\n* Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients.\n\nOUTLINE: Patients are assigned to one of two treatment groups.\n\n* Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1.\n* Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I.\n\nTreatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for 4 weeks and then monthly for 3 months.\n\nPROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed prostate cancer\n* Disease progression after prior castration\n\n * At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart\n* New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI\n* Testosterone no greater than 50 ng/mL\n\n * Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy\n* Progression of disease after discontinuation of prior anti-androgen therapy\n* No requirement for palliative therapy within the past 12 weeks\n* No active CNS or epidural primary tumor OR active CNS or epidural metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,500/mm3\n* Platelet count greater than 100,000/mm3\n\nHepatic:\n\n* Bilirubin less than 1.5 mg/dL\n* Gamma-glutamyl-transferase less than upper limit of normal (ULN)\n* AST less than ULN\n* PT less than 14 seconds\n* No prior autoimmune hepatitis\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No clinically significant cardiac disease (New York Heart Association class III or IV)\n\nPulmonary:\n\n* No severe debilitating pulmonary disease\n\nOther:\n\n* Fertile patients must use effective contraception\n* No active uncontrolled infection or infection requiring IV antibiotics\n* No prior autoimmune disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior murine protein for diagnostic or therapeutic purposes\n* No other concurrent anticancer immunotherapy\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy and recovered\n* No concurrent anticancer chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent anticancer hormonal therapy\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy and recovered\n* Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion\n\nSurgery:\n\n* See Disease Characteristics\n* No concurrent surgery\n\nOther:\n\n* Recovered from all prior therapy\n* At least 4 weeks since prior therapeutic investigational anticancer drugs\n* At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug\n* No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans\n* No other concurrent therapeutic investigational anticancer agents\n* No concurrent participation in other therapeutic clinical trial with an experimental drug'}, 'identificationModule': {'nctId': 'NCT00024232', 'briefTitle': 'Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer', 'orgStudyIdInfo': {'id': 'MSKCC-01030'}, 'secondaryIdInfos': [{'id': 'CDR0000068903', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-G01-2013'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'monoclonal antibody huJ591', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael Morris, 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'}]}}}