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

Phase 2

• Conditions: Cutaneous T-cell Lymphoma; Mycosis Fungoides
• Interventions: Radiation: Total skin electron beam therapy (TSEBT); Drug: mechlorethamine gel 0.016%

• Registration Number: NCT02881749
• Lead Sponsor: Thomas Jefferson University

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30
• Study Start: 2016-09
• Primary Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 1. Male or Female
• ≥ 18 years of age
• 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
• Eligible, in the opinion of the investigator, for low dose TSEBT over the course of two weeks.
• 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.
• Patients who do not have their disease downgrade to stage IA or IB 30 days following low dose 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
• Decisionally-impaired individuals, prisoners, and vulnerable populations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TSEBT & mechlorethamine gel 0.016%	Total skin electron beam therapy (TSEBT)	All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT.
TSEBT & mechlorethamine gel 0.016%	mechlorethamine gel 0.016%	All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT.

Primary Outcome Measures

Name	Time	Method
Time to progression	One year	To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.

Secondary Outcome Measures

Name	Time	Method
Response rate (CR and PR)	One year	To assess the response rate (CR and PR) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen. . CR and PR are defined as the standard oncology criteria for complete response (100% reduction from the baseline score) and partial response (50% to \<100% reduction from the baseline score).