Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00899951
Status:
TERMINATED
Last Update Posted:
2013-04-18
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studying Fentanyl in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}, {'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D064090', 'term': 'Intraocular Lymphoma'}, {'id': 'C580364', 'term': 'Pdgfra-Associated Chronic Eosinophilic Leukemia'}, {'id': 'D015467', 'term': 'Leukemia, Neutrophilic, Chronic'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D008998', 'term': 'Monoclonal Gammopathy of Undetermined Significance'}, {'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of fentanyl citrate', 'timeFrame': 'two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'accelerated phase chronic myelogenous leukemia', 'acute undifferentiated leukemia', 'adult acute lymphoblastic leukemia in remission', 'adult acute myeloid leukemia in remission', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(15;17)(q22;q12)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'blastic phase chronic myelogenous leukemia', 'chronic myelomonocytic leukemia', 'chronic phase chronic myelogenous leukemia', 'mast cell leukemia', 'meningeal chronic myelogenous leukemia', 'progressive hairy cell leukemia, initial treatment', 'prolymphocytic leukemia', 'recurrent adult acute lymphoblastic leukemia', 'recurrent adult acute myeloid leukemia', 'recurrent adult T-cell leukemia/lymphoma', 'refractory chronic lymphocytic leukemia', 'refractory hairy cell leukemia', 'relapsing chronic myelogenous leukemia', 'secondary acute myeloid leukemia', 'stage 0 chronic lymphocytic leukemia', 'stage I adult T-cell leukemia/lymphoma', 'stage I chronic lymphocytic leukemia', 'stage II adult T-cell leukemia/lymphoma', 'stage II chronic lymphocytic leukemia', 'stage III adult T-cell leukemia/lymphoma', 'stage III chronic lymphocytic leukemia', 'stage IV adult T-cell leukemia/lymphoma', 'stage IV chronic lymphocytic leukemia', 'T-cell large granular lymphocyte leukemia', 'recurrent adult Hodgkin lymphoma', 'stage I adult Hodgkin lymphoma', 'stage II adult Hodgkin lymphoma', 'stage III adult Hodgkin lymphoma', 'stage IV adult Hodgkin lymphoma', 'anaplastic large cell lymphoma', 'angioimmunoblastic T-cell lymphoma', 'cutaneous B-cell non-Hodgkin lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'stage I cutaneous T-cell non-Hodgkin lymphoma', 'stage II cutaneous T-cell non-Hodgkin lymphoma', 'stage III cutaneous T-cell non-Hodgkin lymphoma', 'stage IV cutaneous T-cell non-Hodgkin lymphoma', 'recurrent mycosis fungoides/Sezary syndrome', 'stage I mycosis fungoides/Sezary syndrome', 'stage II mycosis fungoides/Sezary syndrome', 'stage III mycosis fungoides/Sezary syndrome', 'stage IV mycosis fungoides/Sezary syndrome', 'adult grade III lymphomatoid granulomatosis', 'adult nasal type extranodal NK/T-cell lymphoma', 'Waldenström macroglobulinemia', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma', 'contiguous stage II adult Burkitt lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse mixed cell lymphoma', 'contiguous stage II adult diffuse small cleaved cell lymphoma', 'contiguous stage II adult immunoblastic large cell lymphoma', 'contiguous stage II adult lymphoblastic lymphoma', 'contiguous stage II grade 1 follicular lymphoma', 'contiguous stage II grade 2 follicular lymphoma', 'contiguous stage II grade 3 follicular lymphoma', 'contiguous stage II mantle cell lymphoma', 'contiguous stage II marginal zone lymphoma', 'contiguous stage II small lymphocytic lymphoma', 'stage I adult Burkitt lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage I adult diffuse mixed cell lymphoma', 'stage I adult diffuse small cleaved cell lymphoma', 'stage I adult immunoblastic large cell lymphoma', 'stage I adult lymphoblastic lymphoma', 'stage I grade 1 follicular lymphoma', 'stage I grade 2 follicular lymphoma', 'stage I grade 3 follicular lymphoma', 'stage I mantle cell lymphoma', 'stage I marginal zone lymphoma', 'stage I small lymphocytic lymphoma', 'noncontiguous stage II adult Burkitt lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse mixed cell lymphoma', 'noncontiguous stage II adult diffuse small cleaved cell lymphoma', 'noncontiguous stage II adult immunoblastic large cell lymphoma', 'noncontiguous stage II adult lymphoblastic lymphoma', 'noncontiguous stage II grade 1 follicular lymphoma', 'noncontiguous stage II grade 2 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'noncontiguous stage II marginal zone lymphoma', 'noncontiguous stage II small lymphocytic lymphoma', 'stage III adult Burkitt lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage III adult diffuse mixed cell lymphoma', 'stage III adult diffuse small cleaved cell lymphoma', 'stage III adult immunoblastic large cell lymphoma', 'stage III adult lymphoblastic lymphoma', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage III mantle cell lymphoma', 'stage III marginal zone lymphoma', 'stage III small lymphocytic lymphoma', 'stage IV adult Burkitt lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'stage IV adult lymphoblastic lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV mantle cell lymphoma', 'stage IV marginal zone lymphoma', 'stage IV small lymphocytic lymphoma', 'recurrent adult Burkitt lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult grade III lymphomatoid granulomatosis', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'intraocular lymphoma', 'primary central nervous system non-Hodgkin lymphoma', 'primary central nervous system Hodgkin lymphoma', 'post-transplant lymphoproliferative disorder', 'chronic eosinophilic leukemia', 'chronic neutrophilic leukemia', 'primary myelofibrosis', 'essential thrombocythemia', 'polycythemia vera', 'extramedullary plasmacytoma', 'isolated plasmacytoma of bone', 'monoclonal gammopathy of undetermined significance', 'stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma', 'primary systemic amyloidosis', 'refractory multiple myeloma', 'de novo myelodysplastic syndromes', 'previously treated myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'myelodysplastic/myeloproliferative neoplasm, unclassifiable', 'pain'], 'conditions': ['Brain and Central Nervous System Tumors', 'Chronic Myeloproliferative Disorders', 'Leukemia', 'Lymphoma', 'Lymphoproliferative Disorder', 'Multiple Myeloma and Plasma Cell Neoplasm', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms', 'Pain', 'Precancerous Condition', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment.\n\nPURPOSE: This research study is looking at fentanyl in patients with cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To describe the pharmacokinetics of prolonged intravenous infusions of fentanyl citrate in adult patients with cancer.\n\nOUTLINE: Patients undergo blood sample collection before and after discontinuation of fentanyl citrate therapy (10 days total). Pharmacokinetic analysis is performed on the samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'cancer pts', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer\n* Inpatient at the Johns Hopkins Hospital Cancer Center undergoing pain treatment with continuous infusion fentanyl citrate for ≥ 5 days\n\nPATIENT CHARACTERISTICS:\n\n* Willing to change to an alternative opioid\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 72 hours since transdermal fentanyl citrate administration\n* At least 12 hours since transmucosal fentanyl citrate administration\n* No known requirement for continued opioid therapy with any fentanyl citrate products after discontinuation of fentanyl citrate therapy'}, 'identificationModule': {'nctId': 'NCT00899951', 'briefTitle': 'Studying Fentanyl in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients', 'orgStudyIdInfo': {'id': 'J06129 CDR0000600337'}, 'secondaryIdInfos': [{'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'JHOC-J06129'}, {'id': 'JHOC-NA-00006329'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'receiving fentaly citrate', 'interventionNames': ['Drug: fentanyl citrate', 'Other: pharmacological study']}], 'interventions': [{'name': 'fentanyl citrate', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1']}, {'name': 'pharmacological study', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Stuart A. Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}