Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT00101257
Status:
COMPLETED
Last Update Posted:
2010-05-07
First Post:
2005-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2005-01-07', 'studyFirstSubmitQcDate': '2005-01-07', 'lastUpdatePostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and toxicity'}, {'measure': 'Duration of in vivo persistence'}, {'measure': 'Antitumor effects'}]}, 'conditionsModule': {'keywords': ['recurrent ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'peritoneal cavity cancer'], 'conditions': ['Ovarian Cancer', 'Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer.\n* Determine the duration of in vivo persistence of this drug in these patients.\n\nSecondary\n\n* Determine the antitumor effect of this drug in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients undergo leukapheresis for collection of T cells. Responder T cells are stimulated in vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed with NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive antigen-specific T cells IV over 30 minutes.\n\nCohorts of 3-6 patients receive escalating doses of autologous CD4-positive antigen-specific T cells 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.\n\nPatients are followed at 4, 8, and 12 weeks and then periodically thereafter for survival.\n\nPROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:\n\n * Progressive\\* or persistent\\* disease during or after primary chemotherapy\n * Recurrent disease \\< 6 months after completion of primary therapy that had resulted in a complete response\n * Persistent\\* or recurrent disease after second-line or additional therapies NOTE: \\*Progression or persistence can be based on serological (CA 125 \\> 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings\n* Tumor expressing NY-ESO-1 determined by IHC or RT-PCR\n* HLA type expressing DPB\\*0401, DPB1\\*0201, DRB1\\*07\n* No CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 75\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* More than 16 weeks\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL\n\nCardiovascular\n\n* No congestive heart failure\\*\n* No clinically significant hypotension\\*\n* No symptoms of coronary artery disease\\*\n* No cardiac arrhythmias on EKG requiring drug therapy\\*\n* No history of cardiovascular disease\\*\n* No other significant cardiovascular abnormalities\\* NOTE: \\*Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation\n\nPulmonary\n\n* FEV\\_1 ≥ 60% of predicted\\*\n* DLCO ≥ 55%\\* NOTE: \\*Patients with clinically significant pulmonary dysfunction only\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n* No active infection\n* No oral temperature \\> 38.2°C within the past 72 hours\n* No systemic infection requiring chronic maintenance or suppressive therapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior standard or experimental chemotherapy\n\nEndocrine therapy\n\n* No concurrent systemic corticosteroids except for treatment-related toxicity\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* At least 3 weeks since prior immunosuppressive therapy\n* More than 3 weeks since prior investigational drugs and recovered\n* No other concurrent investigational agents\n* No concurrent pentoxifylline'}, 'identificationModule': {'nctId': 'NCT00101257', 'briefTitle': 'Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': '1942.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1942.00'}, {'id': 'CDR0000402870', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic autologous lymphocytes', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Cassian Yee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}}}}