Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 12:12 AM
Study NCT ID:
NCT01644968
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicity', 'timeFrame': '28 Days', 'description': 'A dose limiting toxicity is defined as any grade \\>=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.'}], 'secondaryOutcomes': [{'measure': 'Immune Response', 'timeFrame': 'Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.', 'description': 'Blood tests and leukapheresis product will be collected to determine the response to three types of reporter antigens: (1) new antigen (keyhole limpet hemocyanin (KLH)), (2) recall protein antigen (tetanus), and (3) viral antigen (cytomegalovirus (CMV)). Changes in the number of antigens will be used to determine immune response.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic carcinoma', 'lymphoma', 'sarcoma', 'anti-OX40'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '24177180', 'type': 'DERIVED', 'citation': 'Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.', 'detailedDescription': 'This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.\n* ECOG performance status 0, 1, 2\n* No active bleeding\n* No clinical coagulopathy\n* Anticipated lifespan greater than 12 weeks\n\nExclusion Criteria:\n\n* Active residual toxicity from prior therapies\n* Active Infection\n* HIV positive\n* Hepatitis B or C positive\n* Pregnant or nursing women\n* Requirement for oral steroids\n* Brain metastases\n* Presence or history of autoimmune disease\n* Shellfish or tetanus allergy\n* Splenomegaly\n* Lymph nodes greater than 10 cm in maximal diameter\n* Uncontrolled angina or class II or IV heart failure'}, 'identificationModule': {'nctId': 'NCT01644968', 'briefTitle': 'Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': 'Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.', 'orgStudyIdInfo': {'id': '03-066A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KLH + anti-OX40', 'description': 'Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine', 'interventionNames': ['Drug: Cohort 1 anti-OX40', 'Drug: Cohort 2 anti-OX40', 'Drug: Cohort 3 anti-OX40', 'Biological: Tetanus Day 29', 'Biological: KLH Day 1']}, {'type': 'EXPERIMENTAL', 'label': 'Tetanus vaccine + anti-OX40', 'description': 'Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH', 'interventionNames': ['Drug: Cohort 1 anti-OX40', 'Drug: Cohort 2 anti-OX40', 'Drug: Cohort 3 anti-OX40', 'Biological: Tetanus Day 1', 'Biological: KLH Day 29']}], 'interventions': [{'name': 'Cohort 1 anti-OX40', 'type': 'DRUG', 'description': '0.1 mg/kg anti-OX40 on days 1, 3, and 5', 'armGroupLabels': ['KLH + anti-OX40', 'Tetanus vaccine + anti-OX40']}, {'name': 'Cohort 2 anti-OX40', 'type': 'DRUG', 'description': '.4 mg/kg anti-OX40 on days 1, 3, and 5', 'armGroupLabels': ['KLH + anti-OX40', 'Tetanus vaccine + anti-OX40']}, {'name': 'Cohort 3 anti-OX40', 'type': 'DRUG', 'description': '2.0 mg/kg anti-OX40 on days 1, 3, and 5', 'armGroupLabels': ['KLH + anti-OX40', 'Tetanus vaccine + anti-OX40']}, {'name': 'Tetanus Day 29', 'type': 'BIOLOGICAL', 'otherNames': ['Tetanus Toxoid, Tetanus Toxoid Adsorbed'], 'description': 'Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29', 'armGroupLabels': ['KLH + anti-OX40']}, {'name': 'Tetanus Day 1', 'type': 'BIOLOGICAL', 'otherNames': ['Tetansu Toxoid, Tetanus Toxoid Adsorbed.'], 'description': 'Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.', 'armGroupLabels': ['Tetanus vaccine + anti-OX40']}, {'name': 'KLH Day 1', 'type': 'BIOLOGICAL', 'otherNames': ['Immucothel.'], 'description': '1 mg KLH in 1 cc diluent subcutaneously on Day 1.', 'armGroupLabels': ['KLH + anti-OX40']}, {'name': 'KLH Day 29', 'type': 'BIOLOGICAL', 'otherNames': ['Immucothel.'], 'description': '1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.', 'armGroupLabels': ['Tetanus vaccine + anti-OX40']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Cancer Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Brendan Curti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Health & Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}