Status:
WITHDRAWN
Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Actelion
Conditions:
Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 bea...
Detailed Description
PRIMARY OBJECTIVES: I. 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 (Val...
Eligibility Criteria
Inclusion
- Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study
- Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator
- Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease
- Availability of subject to be observed for up to 18 months post-screening evaluation
- Life expectancy greater than 6 months
Exclusion
- Pregnant or breast-feeding females
- 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
- 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
- Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
- Minimum 3 weeks since prior systematic treatment or phototherapy
- Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03288818
Start Date
August 1 2018
End Date
December 1 2021
Last Update
April 29 2025
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107