Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 5:22 PM
Study NCT ID:
NCT00098332
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2004-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2004-12-07', 'studyFirstSubmitQcDate': '2004-12-07', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent 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 II mycosis fungoides/Sezary syndrome', 'stage III mycosis fungoides/Sezary syndrome', 'stage IV mycosis fungoides/Sezary syndrome'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.\n\nPURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.\n* Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed periodically.\n\nPROJECTED ACCRUAL: Not specified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed cutaneous T-cell lymphoma\n\n * Refractory to prior treatment\n * Stage IIA, IIB, III, IVA, or IVB disease\n* Measurable disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* AST and/or ALT ≤ 3 times upper limit of normal\n* Hepatitis B and/or hepatitis C negative\n\nRenal\n\n* Creatinine clearance ≥ 40 mL/min\n\nImmunologic\n\n* Human T-cell lymphotrophic virus type I (HTLV-I) negative\n* HIV negative\n* No active serious infection not controlled by antibiotics\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No known impaired absorption of the gastrointestinal tract\n* No other illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* More than 21 days since prior chemotherapy and recovered\n\nEndocrine therapy\n\n* Concurrent topical corticosteroids allowed provided patient remains on a stable dose\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 30 days since prior investigational agents and recovered\n* No concurrent tanning bed use\n* No other concurrent therapy for cutaneous T-cell lymphoma'}, 'identificationModule': {'nctId': 'NCT00098332', 'briefTitle': 'Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'BIOCRYST-BCX1777-C-04-105'}, 'secondaryIdInfos': [{'id': 'CDR0000405886', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'forodesine hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Comprehensive Cancer Center - Stanford', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at UC Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34461', 'city': 'Lecanto', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer and Blood Disease Center', 'geoPoint': {'lat': 28.85165, 'lon': -82.4876}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber/Brigham and Women's Cancer Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Charles M. Barrett Cancer Center at University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioCryst Pharmaceuticals', 'class': 'INDUSTRY'}}}}