Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT00603460
Status:
WITHDRAWN
Last Update Posted:
2017-05-02
First Post:
2008-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DCVax-L Vaccination With CD3/CD28 Costimulated Autologous T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease status will be assessed with CT (or MRI) of chest/abdomen/pelvis at enrollment, after vaccine 2 and at the conclusion of the study . Rates of disease progression will be recorded at the time of study conclusion.', 'timeFrame': 'Enrollment, 3 months after enrollment, End of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian Cancer', 'Peritoneal Cancer'], 'conditions': ['Ovarian Cancer', 'Primary Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': 'Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous vaccine with DC loaded in vitro with autologous tumor lysate.\n\nPhase I Subjects enrolled in this study will receive leukapheresis; followed by cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a single DCVax-L vaccination, to establish feasibility and safety of this approach.\n\nPrimary Objectives of Phase I\n\nTo determine the feasibility and safety of administering vaccine-primed, ex vivo CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine.\n\nPhase II\n\nTwenty-two additional subjects will be randomized to receive either:\n\n* ARM-IIA: maintenance DCVax-L vaccination, in combination with oral metronomic cyclophosphamide, or\n* ARM-IIB: leukapheresis, followed by cyclophosphamide/fludarabine-induced lymphodepletion, followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells, followed by maintenance DCVax-L vaccination, plus oral metronomic cyclophosphamide.\n\nPrimary Objective of Phase II\n\nTo assess the distribution of progression-free survival at 6 months for patients treated with maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L boost vaccination and metronomic oral cyclophosphamide.', 'detailedDescription': 'Description of treatment for Phase I:\n\n* Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine.\n* If subjects have not received DCVax-L vaccination within the last 3-4 weeks, and if DCVax-L is available, subjects have the option of receiving one dose of DCVax-L after enrolment, to boost the frequency of vaccine-primed T cells.\n* Subjects will receive a single course of outpatient lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 days) and intravenous fludarabine (30 mg/m2/d for 3 days) both administered on days 8 to 10.\n* Ex vivo CD3/CD28-costimulated lymphocytes will be infused \\~2 days after last day of fludarabine infusion.\n* Patients will receive DCVax-L vaccine \\~24-48 hrs after T cell infusion.\n* Subjects will be contacted every 6 months for 5 years for survival.\n\nDescription of treatment for Phase II:\n\nIn ARM-IIA:\n\n* Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine.\n* Subjects will receive intradermal vaccinations with DCVax-L every 8 weeks, for four cycles total. The first vaccine will be administered on day 0, which can be no sooner than 4 weeks from previous DCVax-L vaccination related to clinical study UPCC-11807.\n* Subjects will receive oral cyclophosphamide at metronomic schedule and dose (50 mg daily) every other week, starting \\~3 weeks after DCVax-L in every vaccine cycle.\n* Patients will be offered (with the right to refuse) CT-guided needle biopsy or needle aspiration of malignant effusion after the second vaccine.\n\nIn ARM-IIB:\n\n* Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine.\n* Subjects will undergo \\~10-15 liter leukapheresis to derive vaccine-primed peripheral blood lymphocytes (PBL) on day 0. The apheresis material will be transferred to the Cell and Vaccine Facility at the University of Pennsylvania (Penn CVPF) for T cell manufacturing.\n* If subjects have not received DCVax-L vaccination within the last 3-4 weeks, and if DCVax-L is available, subjects have the option of receiving one dose of DCVax-L after enrolment, to boost the frequency of vaccine-primed T cells.\n* Subjects will receive a single course of outpatient lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 days) and intravenous fludarabine (30 mg/m2/d for 3 days).\n* Ex vivo CD3/CD28-costimulated lymphocytes will be infused \\~2 days after last day of fludarabine infusion.\n* Patients will receive DCVax-L vaccine boosts every 8 weeks for a total of four vaccines. The first DCVax-L will be given \\~24-48 hrs after T cell infusion.\n* Following DCVax-L, subjects will receive oral cyclophosphamide at metronomic schedule and dose (50 mg daily) every other week x 3 cycles, starting \\~3 weeks after DCVax-L in every vaccine cycle.\n* Patients will be offered (with the right to refuse) CT-guided needle biopsy or needle aspiration of malignant effusion \\~1-2 weeks after the second vaccine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation in UPCC 11807 (A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Loaded with Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer)\n* PS \\< 2\n* Subject must have tumor lysate sufficient to prepare at least 4 DCVax-L vaccines\n* 18 years of age or older\n* Life expectancy \\> 4 months\n* Signed Informed Consent\n* Normal organ and bone marrow function defined by:\n* ANC ≥ 1,000/μl\n* Platelets \\>100,000/μl\n* AST(SGOT)/ALT(SGPT) \\< 2.5 X institutional upper limit of normal\n* Bilirubin \\<2.0 mg/dL unless secondary to bile duct blockage by tumor\n* Creatinine \\<1.5 X the upper limit of normal\n\nExclusion Criteria:\n\n* Subjects with the following:\n* known brain metastases\n* renal insufficiency\n* liver failure\n* organ allograft\n* known autoimmune/collagen vascular disorders\n* pregnant or breast feeding\n* non-healing wounds, ulcers, or bone fractures\n* positive for serum anti-Yo (cdr2) antibodies\n* uncontrolled hypertension\n* Myocardial infarction or unstable angina within 6 months prior to registration\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure'}, 'identificationModule': {'nctId': 'NCT00603460', 'briefTitle': 'DCVax-L Vaccination With CD3/CD28 Costimulated Autologous T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Phase-I/II Randomized Trial of Maintenance Vaccination Combined With Metronomic Cyclophosphamide w/wo Adoptive Transfer of CD3/CD28-CoStimulated T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer Previously Vaccinated DCVax-L', 'orgStudyIdInfo': {'id': 'UPCC 01808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Biological: DCVax-L and T Cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Biological: DCVax-L and T Cells']}], 'interventions': [{'name': 'DCVax-L and T Cells', 'type': 'BIOLOGICAL', 'otherNames': ['Cytoxan', 'Avastin', 'DCVax-L'], 'description': 'Arm A\n\n* Optional DCVax-L prior to chemotherapy\n* Apheresis\n* Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)\n* Infusion of activated T cells\n* DCVax-L vaccine\n* End of study visit\n\nArm B\n\n* Optional DCVax-L prior to chemotherapy\n* Apheresis\n* Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)\n* Infusion of activated T cells\n* DCVax-L vaccine\n* Oral cyclophosphamide (one week on/one week off) for a total for a total of 6 weeks\n* End of study visit', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'George Coukos, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwest Biotherapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}