Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides

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.

Inclusion Criteria:

- 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 Criteria:

- 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