Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-27 @ 10:41 AM
Study NCT ID:
NCT03288818
Status:
WITHDRAWN
Last Update Posted:
2025-04-29
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000588', 'term': 'Amines'}], 'ancestors': [{'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding discontinued', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': 'Up to week 54', 'description': 'Will be evaluated using the Kaplan-Meier estimator of the survival curves.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mycosis Fungoides']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hospitals.jefferson.edu/', 'label': 'Thomas Jefferson University Hospital'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel (Valchlor) regimen.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the response rate (complete response \\[CR\\] and partial response \\[PR\\]) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma\n* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study\n* Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator\n* Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease\n* Availability of subject to be observed for up to 18 months post-screening evaluation\n* Life expectancy greater than 6 months\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data\n* Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT\n* Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment\n* Minimum 3 weeks since prior systematic treatment or phototherapy\n* Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations"}, 'identificationModule': {'nctId': 'NCT03288818', 'briefTitle': 'Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides', 'orgStudyIdInfo': {'id': '16C.514'}, 'secondaryIdInfos': [{'id': 'JT 8557', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose TSEBT, mechlorethamine hydrochloride gel', 'description': 'Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.', 'interventionNames': ['Drug: Mechlorethamine Hydrochloride Gel', 'Procedure: Total Skin Electron Beam Radiation Therapy']}], 'interventions': [{'name': 'Mechlorethamine Hydrochloride Gel', 'type': 'DRUG', 'otherNames': ['Valchlor'], 'description': 'Given topically', 'armGroupLabels': ['low dose TSEBT, mechlorethamine hydrochloride gel']}, {'name': 'Total Skin Electron Beam Radiation Therapy', 'type': 'PROCEDURE', 'otherNames': ['TSEB radiation therapy'], 'description': 'Undergo low dose (TSEBT) Total Skin Electron Beam Therapy', 'armGroupLabels': ['low dose TSEBT, mechlorethamine hydrochloride gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Joya Sahu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Actelion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}