Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00058435
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518318', 'term': 'abagovomab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-04', 'studyFirstSubmitDate': '2003-04-07', 'studyFirstSubmitQcDate': '2003-04-08', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer', 'fallopian tube cancer', 'primary peritoneal cavity cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.\n\nPURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.\n* Determine an optimal dose and route of this vaccine for a phase II study.\n* Determine the immune response induced by this vaccination in these patients.\n* Determine the time to development of objective tumor response in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.\n\n* Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.\n* Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.\n* Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.\n\nPROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer\n\n * Stage II-IV\n* Initially treated with surgery and at least 1 platinum-based chemotherapy regimen\n* Must have relapsed after initial treatment and completed chemotherapy for recurrent disease\n* Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed\n* Complete clinical remission allowed, defined by the following criteria:\n\n * CA 125 no greater than 35 IU/mL\n * No objective evidence of disease by CT scan\n * Normal physical examination\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* WBC at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic\n\n* Bilirubin no greater than 2 times normal\n* ALT no greater than 2 times normal\n* Alkaline phosphatase no greater than 2 times normal\n\nRenal\n\n* Creatinine no greater than 1.5 times normal\n\nOther\n\n* Not pregnant or nursing\n* No potential for child bearing\n* Human antimurine antibody negative\n* HIV negative\n* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No active infection\n* No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)\n* No known immune deficiency (e.g., hypogammaglobulinemia)\n* No known allergy to murine proteins\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 6 weeks since prior interferon\n* At least 6 weeks since prior immunotherapy or biological response modifiers\n* No prior anticancer vaccine\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior cytotoxic or investigational chemotherapy\n\nEndocrine therapy\n\n* No concurrent steroids\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* At least 1 week since prior antibiotics\n* No concurrent cyclosporine\n* No other concurrent immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT00058435', 'briefTitle': 'Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer', 'orgStudyIdInfo': {'id': '02-122'}, 'secondaryIdInfos': [{'id': 'CDR0000288831', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'CELLCONTROL-MSKCC-02122'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'abagovomab', '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': 'Paul Sabbatini, 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'}]}}}