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

NCT03288818 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 16C.514JT 8557
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Will be evaluated using the Kaplan-Meier estimator of the survival curves.

  Up to week 54

Study Arms (1)

low dose TSEBT, mechlorethamine hydrochloride gel

EXPERIMENTAL

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; Procedure: Total Skin Electron Beam Radiation Therapy

Interventions

Mechlorethamine Hydrochloride Gel DRUG

Given topically

Also known as: Valchlor

low dose TSEBT, mechlorethamine hydrochloride gel

Total Skin Electron Beam Radiation Therapy PROCEDURE

Undergo low dose (TSEBT) Total Skin Electron Beam Therapy

Also known as: TSEB radiation therapy

low dose TSEBT, mechlorethamine hydrochloride gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Actelion: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Amines

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

• Joya Sahu, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: August 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)