Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00367718
Status:
WITHDRAWN
Last Update Posted:
2020-05-18
First Post:
2006-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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'count': 0}}, 'statusModule': {'whyStopped': 'PI left JHU and is not able to be reached for updates', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2006-08-21', 'studyFirstSubmitQcDate': '2006-08-21', 'lastUpdatePostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy based on response of measurable disease', 'timeFrame': 'duration of study (4 -6 months)'}], 'secondaryOutcomes': [{'measure': 'EBV viral load', 'timeFrame': 'duration of study (4 -6 months)'}, {'measure': 'toxicities', 'timeFrame': 'duration of study (4 -6 months)'}, {'measure': 'molecular characterization of EBV in Plasma', 'timeFrame': 'duration of study (4 -6 months)'}]}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)\n* metastatic disease or locally recurrent disease not amendable curative therapy\n* Patients must have measurable disease\n* least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.\n* An ECOG performance status of 0-2\n* Absolute neutrophil count (ANC) ≥1500/mm3\n* Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).\n* PLT ≥ 75,000/mm 3\n* Total bilirubin ≤ 2 x upper normal limit (UNL)\n* Serum ALT ≤ 5 x UNL\n* Serum creatinine ≤ 2 mg/dL\n* Serum albumin ≥ 2.5 g/dL\n* No known history of brain or leptomeningeal metastasis.\n* ≥ 18 years of age.\n* Estimated life expectancy ≥ 24 weeks.\n* For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.\n* must be able to give informed written consent\n\nExclusion Criteria:\n\n* Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC\n* Prior BORTEZOMIB therapy\n* Immunotherapy ≤ 4 weeks have elapsed prior to study entry\n* Biologic therapy ≤ 4 weeks have elapsed prior to study entry\n* Radiation therapy ≤ 4 weeks have elapsed prior to study entry\n* Major surgery, or significant traumatic injury ≤3 weeks prior to study entry\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational\n* Evidence of CNS involvement\n* Presence of \\> grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.\n* Patients with significant local symptoms from metastases which is amenable to radiotherapy\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.\n* History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.\n* Uncontrolled intercurrent illness\n* Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.\n* Known history of HIV'}, 'identificationModule': {'nctId': 'NCT00367718', 'briefTitle': 'Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'CTRG-NP04/23/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Velcade', 'type': 'DRUG', 'description': 'velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Johns Hopkin Singapore International Medical Center', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Wen-son Hsieh, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins Singapore-International Medical Center'}, {'name': 'Brigette Ma, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen-Cilag Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}