Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
With
Actelion
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 (Valchlor) regimen.
SECONDARY OBJECTIVES:
I. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides