Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides

PHASE2UnknownINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

August 31, 2020

Conditions
Mycosis FungoidesCutaneous T-cell Lymphoma
Interventions
RADIATION

Total skin electron beam therapy (TSEBT)

"TSEBT will be given in 6 fractions at 2 Gy per fraction every Monday, Wednesday, and Friday over the course of 2 weeks (total TSEBT dosage is 12 Gy). Supplements up to 8 Gy will routinely be applied to the perineum and soles as well as any other shadowed sites involved by disease, such as the inframammary regions, scalp, etc. Discrete tumors may receive additional boost up to 8 Gy."

DRUG

mechlorethamine gel 0.016%

The maintenance period for this study includes one year of weekly mechlorethamine gel 0.016%. This period will not begin until the observation period (30 days) has been completed. During the first week of the maintenance period, patients will apply mechlorethamine gel to the entire body surface daily. After the first week, patients will apply mechlorethamine gel to entire body surface one time per week for the rest of the maintenance period.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Actelion

INDUSTRY

lead

Thomas Jefferson University

OTHER

NCT02881749 - Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides | Biotech Hunter | Biotech Hunter