Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-31 @ 8:02 PM
Study NCT ID:
NCT00053105
Status:
UNKNOWN
Last Update Posted:
2009-07-07
First Post:
2003-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}], 'ancestors': [{'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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-03', 'lastUpdateSubmitDate': '2009-07-04', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent adult diffuse large cell lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'recurrent adult immunoblastic large cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.\n* Determine the dose-limiting toxic effects of this regimen in these patients.\n* Determine the relationship between toxicity and systemic exposure to this regimen in these patients.\n* Determine the safety of this regimen in these patients.\n* Assess the pharmacokinetics of this regimen in these patients.\n* Determine, preliminarily, the efficacy of this regimen in these patients.\n\nOUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone.\n\nPatients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following:\n\n * Diffuse large B-cell lymphoma\n * Transformed NHL\n * Follicular large cell lymphoma\n * Peripheral T-cell lymphoma\n * Unclassified aggressive histology (immunoblastic lymphoma)\n* Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m\\^2)\n* No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 64\n\nPerformance status\n\n* WHO 0-1\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Neutrophil count at least 1,500/mm\\^3\\*\n* Platelet count at least 100,000/mm\\^3\\* NOTE: \\*Lower values may be accepted if evidence of bone marrow involvement\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\\*\\*\n* Alkaline phosphatase no greater than 2 times ULN\\*\\*\n* AST or ALT no greater than 2 times ULN\\*\\*\n* No history or clinical symptoms of hepatitis B or C virus NOTE: \\*\\*Higher values may be accepted if evidence of liver involvement\n\nRenal\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular\n\n* LVEF at least 50% by MUGA\n* No clinically significant cardiovascular abnormalities\n* No New York Heart Association class II-IV heart disease\n* No myocardial infarction within the past 6 months\n* No severe arrhythmia\n* No uncontrolled hypertension\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 6 months after study\n* No history or clinical symptoms of HIV\n* No clinically significant neurological abnormalities\n* No serious uncontrolled infection (NCI CTC grade 3-4)\n* No condition that would place the patient at undue risk or interfere with the study results\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 3 months since prior radioimmunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* At least 1 year since prior platinum or cytarabine (unless complete response to treatment)\n* At least 2 years since prior fludarabine or nitrosoureas\n* No prior cumulative cisplatin greater than 600 mg/m\\^2\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Biologic therapy\n* At least 4 weeks since prior radiotherapy\n* No prior radiotherapy to the whole pelvis\n\nSurgery\n\n* At least 1 week since prior minor surgery and recovered\n* At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered\n\nOther\n\n* At least 1 month since prior investigational drugs\n* Recovered from prior therapy\n* No other concurrent investigational drugs"}, 'identificationModule': {'nctId': 'NCT00053105', 'briefTitle': "Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CDR0000269140'}, 'secondaryIdInfos': [{'id': 'THERADEX-AZA-I-05'}, {'id': 'NOVUSPHARMA-AZA-I-05'}, {'id': 'NOVUSPHARMA-AZA-1401'}, {'id': 'CWRU-050213J'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'methylprednisolone', 'type': 'DRUG'}, {'name': 'pixantrone dimaleate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '90033-0800', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Marlene and Stewart Greenebaum Cancer Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '44106-5055', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Boston Baskin Cancer Group, University Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Luis Fayad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theradex', 'class': 'INDUSTRY'}}}}