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

Mycosis Fungoides Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02881749
• Other study ID #: IRB #16C.514
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 24, 2016
• Last updated: August 29, 2016
• Start date: September 2016

Study information

• Verified date: August 2016
• Source: Thomas Jefferson University
• Contact: Kelly Knoblauch
• Phone: (215) 955-9295
• Email: kelly.knoblauch[@]jefferson.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Actelion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.	One year	No
Secondary	Response rate (CR and PR)	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).	One year	No