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

Mycosis Fungoides Clinical Trial

Official title:

IIS: 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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03288818
• Other study ID #: 16C.514
• Status: Withdrawn
• Phase: Phase 2
• First received: September 18, 2017
• Last updated: January 25, 2018
• Start date: August 2018
• Est. completion date: December 2021

Study information

• Verified date: January 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Mechlorethamine Hydrochloride Gel
Given topically

Procedure:
• Total Skin Electron Beam Radiation Therapy
Undergo low dose (TSEBT) Total Skin Electron Beam Therapy

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	Will be evaluated using the Kaplan-Meier estimator of the survival curves.	Up to week 54

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital