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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mycosis Fungoides
• Intervention / Treatment: Drug: Mechlorethamine Hydrochloride Gel; Procedure: Total Skin Electron Beam Radiation Therapy

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose TSEBT, mechlorethamine hydrochloride gel; Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.	Drug: Mechlorethamine Hydrochloride Gel; Given topically; Other Names: Valchlor; Procedure: Total Skin Electron Beam Radiation Therapy; Undergo low dose (TSEBT) Total Skin Electron Beam Therapy; Other Names: TSEB radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression	Will be evaluated using the Kaplan-Meier estimator of the survival curves.	Up to week 54

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: Actelion
• Investigators: Principal Investigator: Joya Sahu, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2018
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Estimated): December 1, 2021

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Infections; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Bacterial Infections and Mycoses; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Mycoses; Mycosis Fungoides; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Alkylating; Alkylating Agents; Mechlorethamine
• Other Study ID Numbers: 16C.514; JT 8557 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes