Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00935558
Status:
WITHDRAWN
Last Update Posted:
2012-05-31
First Post:
2009-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dendritic Cell Based Therapy for Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706173', 'term': 'lentiviral minigene vaccine of COVID-19 coronavirus'}, {'id': 'D000077596', 'term': 'Thymalfasin'}, {'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patients enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2009-07-08', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine time to progression', 'timeFrame': 'after 8 and 16 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate safety of DC vaccination in combination with AI, to evaluate clinical tumor response, to evaluate treatment induced immune response to p53 end to evaluate duration of tumor and immune responses', 'timeFrame': 'Weekly the first 4 weeks, thereafter biweekly for five months, thereafter monthly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dendritic cell', 'cancer vaccine', 'breast cancer', 'aromatase inhibitor', 'Zadaxin'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17285289', 'type': 'BACKGROUND', 'citation': 'Svane IM, Pedersen AE, Johansen JS, Johnsen HE, Nielsen D, Kamby C, Ottesen S, Balslev E, Gaarsdal E, Nikolajsen K, Claesson MH. Vaccination with p53 peptide-pulsed dendritic cells is associated with disease stabilization in patients with p53 expressing advanced breast cancer; monitoring of serum YKL-40 and IL-6 as response biomarkers. Cancer Immunol Immunother. 2007 Sep;56(9):1485-99. doi: 10.1007/s00262-007-0293-4. Epub 2007 Feb 7.'}, {'pmid': '14985857', 'type': 'BACKGROUND', 'citation': 'Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.', 'detailedDescription': 'Only patients who have tumors \\> 5 % positive for p53 by IHC can be referred to this treatment. All patients will receive standard dosage of AI +/- p53-DC vaccination. Patients who express HLA-A2 will also receive DC vaccination. Patients that do not express HLA-A2 will receive only AI and be regarded as controls.\n\nThe vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6) with p53 peptide-pulsed dendritic cells, followed by monthly injections until progression; proleukin and Zadaxin are used as vaccine adjuvants.\n\nDefined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and loaded with p53 peptides. Frozen preparations of dendritic cells will be prepared using automated cryopreservation.Each patient will receive a minimum of 5x10\\^6 dendritic cells per treatment supplemented with interleukin-2 6 MIU/m² sc per vaccine and 1.6 mg Thymosin 1 alpha sc x 2/week.\n\nToxicity including autoimmunity will be evaluated using the common Toxicity Criteria (CTC).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy.\n* Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age \\>18, PS ≤ 1 and acceptable CBC and blood chemistry results\n\nExclusion Criteria:\n\n* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)\n* Patients with metastatic disease in the central nervous system\n* Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure\n* Patients with acute or chronic infection including HIV, hepatitis og TB\n* Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial\n* Patients who received corticosteroids or other immunosuppressive agents\n* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis\n* Severe hypercalcemia'}, 'identificationModule': {'nctId': 'NCT00935558', 'briefTitle': 'Dendritic Cell Based Therapy for Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy.', 'orgStudyIdInfo': {'id': 'MA 0822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatase inhibitor and DC vaccination', 'description': 'the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2', 'interventionNames': ['Biological: DC vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aromatase inhibitor', 'description': 'the HLA-A2 negative patients will receive AI only', 'interventionNames': ['Biological: DC vaccine', 'Drug: aromatase inhibitor']}], 'interventions': [{'name': 'DC vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['dendritic cell vaccine', 'Thymosin 1 alpha, Zadaxin®, Sigma-Tau', 'Interleukin-2, Proleukin®, Chiron B.V.', 'Aromatase inhibitor:Exemestane, (Aromasin®), Pfizer', 'or Femar®,letrozol, Novartis Healthcare', 'or Arimidex®, anastrozol, AstraZeneca'], 'description': 'DC vaccination regime consist of primary 10 intradermal injections of 1-2 weeks interval. At the time of each vaccine 6 MIU/m² IL-2 will be administered sc. Zadaxin 1.6 mg is injected sc twice a week. and tablet Aromatase inhibitor is administered ; Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily', 'armGroupLabels': ['Aromatase inhibitor', 'Aromatase inhibitor and DC vaccination']}, {'name': 'aromatase inhibitor', 'type': 'DRUG', 'otherNames': ['Aromasin®, exemestane, Pfizer', 'Femar®, letrozol, Novartis Healthcare', 'Arimidex, anastrozol, AstraZeneca'], 'description': 'Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily', 'armGroupLabels': ['Aromatase inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Oncology, Copenhagen University Hospital, Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Inge Marie Svane, prof MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev; Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inge Marie Svane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof, MD, PhD', 'investigatorFullName': 'Inge Marie Svane', 'investigatorAffiliation': 'Herlev Hospital'}}}}