Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-28 @ 8:48 PM
Study NCT ID:
NCT00002818
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Cytarabine Plus Deoxycytidine in Treating With Acute Myelogenous Leukemia or Other Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'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': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D015448', 'term': 'Leukemia, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2004-04-21', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent adult Hodgkin lymphoma', 'refractory multiple myeloma', 'recurrent adult acute myeloid leukemia', 'recurrent adult acute lymphoblastic leukemia', 'relapsing chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent adult Burkitt lymphoma', 'drug/agent toxicity by tissue/organ', 'recurrent mantle cell lymphoma', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma'], 'conditions': ['Drug/Agent Toxicity by Tissue/Organ', 'Leukemia', 'Lymphoma', 'Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Deoxycytidine may protect patients from the side effects of high-dose cytarabine.\n\nPURPOSE: Phase I trial to study the effectiveness of high-dose cytarabine given with deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other lymphoma or leukemia.', 'detailedDescription': 'OBJECTIVES: I. Estimate the lowest dose of deoxycytidine (dC) that can be given as a host protective agent in conjunction with high dose cytarabine (HD ARA-C) in patients with refractory acute myelogenous leukemia or other hematologic malignancies. II. Determine the maximum tolerated dose and dose-limiting toxic effects of HD ARA-C/dC in these patients. III. Characterize the pharmacokinetics of continuously administered HD ARA-C/dC in these patients. IV. Characterize, when possible, the pharmacodynamics of HD ARA-C, dC, and their metabolites in blasts obtained from leukemic patients participating in this trial. V. Recommend the lowest possible dose of dC that can be given in combination with HD ARA-C in future phase II trials.\n\nOUTLINE: This is a dose escalation study. Patients receive deoxycytidine IV over 120 hours. Beginning 12 hours after initiation of deoxycytidine, patients receive high dose cytarabine IV over 96 hours. Patients achieving complete response receive no further therapy. Patients achieving partial response or initial complete response and subsequent relapse receive an additional course of therapy. Cohorts of 3-6 patients receive escalating doses of deoxycytidine and high dose cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.\n\nPROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: One of the following histologically documented hematologic malignancies: Acute myelogenous leukemia Failed or relapsed following conventional dose chemotherapy (e.g., doxorubicin, cytarabine) or high dose cytarabine (HD ARA-C) Chronic myelogenous leukemia in blast crisis that has failed at least 1 conventional antileukemic regimen Acute lymphoblastic leukemia (ALL) that is relapsed following or initially refractory to conventional therapy Failed at least 1 salvage regimen for ALL Disease refractory to conventional HD ARA-C allowed Primarily refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma Failed at least 1 conventional second or third generation regimen (e.g., ProMACE-CytaBOM) Refractory multiple myeloma Not eligible for protocols of higher priority and no alternative forms of therapy available that offer a reasonable chance of palliation or cure\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine clearance at least 40 mL/min Pulmonary: Pulse oximetry greater than 88% in patients with a history of pulmonary disease Other: No major concurrent disease that renders patient a poor medical risk No uncontrolled infection Disease related fever allowed at investigator's discretion No mental incapacity that precludes informed consent No incarcerated patients Not pregnant Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY: Not specified Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (24 hours since hydroxyurea) and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 30% or more of bone marrow At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified"}, 'identificationModule': {'nctId': 'NCT00002818', 'briefTitle': 'High-Dose Cytarabine Plus Deoxycytidine in Treating With Acute Myelogenous Leukemia or Other Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': "Phase I and Clinical Pharmacokinetic De-Escalation Study of 2'-Deoxycitidine Administered as a Continuous Infusion in Conjunction With a Continuous Infusion of High-Dose ARA-C in Patients With Refractory Acute Myelogenous Leukemia", 'orgStudyIdInfo': {'id': 'CDR0000064976'}, 'secondaryIdInfos': [{'id': 'P30CA016059', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016059', 'type': 'NIH'}, {'id': 'MCV-MCC-9409-2CC', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}, {'id': 'VCU-FDR000637', 'type': 'OTHER', 'domain': 'Food and Drug Administration'}, {'id': 'NCI-V96-0966', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'deoxycytidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298-0037', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Steven Grant, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massey Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}