NCT02881749

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).

Conditions

• Mycosis Fungoides
• Cutaneous T-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-08-01
• First posted: 2016-08-29
• Last updated: 2016-08-30