Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT00004916
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ifosfamide, Teniposide, and Paclitaxel in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013713', 'term': 'Teniposide'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2011-07-01', 'completionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2000-03-07', 'dispFirstSubmitQcDate': '2011-07-01', 'studyFirstSubmitQcDate': '2003-05-13', 'dispFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent grade 3 follicular lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult Burkitt 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/II trial to study the effectiveness of ifosfamide, teniposide, and paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the toxicities associated with the combination of ifosfamide, teniposide, and weekly paclitaxel in patients with relapsed non-Hodgkin's lymphoma.\n* Evaluate response rate and time to disease progression in these patients treated with this regimen.\n\nOUTLINE: This is a dose escalation study of teniposide. Patients are stratified according to whether they proceed to stem cell transplant or not.\n\nPatients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks, teniposide IV over 2 hours on day 1 every 3 weeks, and paclitaxel IV over 1 hour weekly. Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity. Patients proceeding to stem cell transplant continue treatment for 36 days. Peripheral blood stem cells (PBSC) may be harvested at this time if autologous transplant is planned. Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant.\n\nCohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed intermediate or high grade non-Hodgkin\'s lymphoma\n\n * No lymphoblastic or small cleaved lymphoma\n* Progressive disease following doxorubicin based chemotherapy\n\n * No more than 2 prior treatment regimens\n* Measurable or evaluable disease NOTE: A new classification scheme for adult non-Hodgkin\'s lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin no greater than 2 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* No significant cardiac disease\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No active or uncontrolled second malignancy\n* No other medical problems that would preclude therapy\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior stem cell transplant allowed\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00004916', 'briefTitle': "Ifosfamide, Teniposide, and Paclitaxel in Treating Patients With Relapsed Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma', 'orgStudyIdInfo': {'id': 'NU 98H2'}, 'secondaryIdInfos': [{'id': 'NU-98H2'}, {'id': 'NCI-G00-1711'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'paclitaxel', 'type': 'DRUG'}, {'name': 'teniposide', 'type': 'DRUG'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Leo I. Gordon, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}