Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00004106
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], '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': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 29}}, 'statusModule': {'whyStopped': 'Per Data Monitoring Committee given the poor/inadequate accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2011-07-01', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '1999-12-10', 'dispFirstSubmitQcDate': '2011-07-01', 'studyFirstSubmitQcDate': '2003-01-26', 'dispFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'After every 2 cycles of therapy', 'description': 'Disease response will be assessed using bi-dimensional measurements of lesions with clearly defined margins by medical photograph (skin lesion) or by radiological imaging (internal lesions).'}]}, 'conditionsModule': {'keywords': ['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 cutaneous T-cell non-Hodgkin lymphoma', 'stage I mycosis fungoides/Sezary syndrome', 'stage II mycosis fungoides/Sezary syndrome', 'stage III mycosis fungoides/Sezary syndrome', 'stage IV mycosis fungoides/Sezary syndrome', 'recurrent mycosis fungoides/Sezary syndrome'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.\n* Determine the toxic effects of this drug in these patients.\n* Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 12-37 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 mycosis fungoides or Sezary syndrome\n\n * Stage IB-IVB disease\n * Must have failed at least one prior systemic therapy\n * Generalized erythroderma allowed\n* Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only\n\n * Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2 OR\n* WHO 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 2.2 mg/dL\n* SGOT or SGPT no greater than 2 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2 times ULN\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* No New York Heart Association class III or IV heart disease\n* No clinically significant peripheral venous insufficiency\n\nOther:\n\n* HIV negative\n* No poorly controlled diabetes mellitus\n* No acute infection requiring IV antibiotics\n* No other medical condition that would prevent ingestion or absorption of oral medication\n* No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior biologic therapy and recovered\n* No concurrent growth factors or epoetin alfa\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy and recovered\n\nEndocrine therapy:\n\n* At least 4 weeks since prior topical steroids\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 2 weeks since prior radiotherapy for local control or palliation and recovered\n\nSurgery:\n\n* Recovered from prior major surgery\n\nOther:\n\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00004106', 'briefTitle': 'Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome', 'orgStudyIdInfo': {'id': 'NU FDA97H3'}, 'secondaryIdInfos': [{'id': 'NU-FDA97H3'}, {'id': 'NCI-G99-1597'}, {'id': 'STU00010001', 'type': 'OTHER', 'domain': 'Northwestern University IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temozolomide', 'type': 'DRUG', 'description': 'Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Comprehensive Cancer Center at Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Timothy M. Kuzel, 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'}}}}