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

NCT ID: NCT03288818

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Mycosis Fungoides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mechlorethamine Hydrochloride Gel

Intervention Type: DRUG

Given topically

Total Skin Electron Beam Radiation Therapy

Intervention Type: PROCEDURE

Undergo low dose (TSEBT) Total Skin Electron Beam Therapy

Interventions

Mechlorethamine Hydrochloride Gel

Given topically

Intervention Type: DRUG

Total Skin Electron Beam Radiation Therapy

Undergo low dose (TSEBT) Total Skin Electron Beam Therapy

Intervention Type: PROCEDURE

Other Intervention Names

Valchlor; TSEB radiation therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joya Sahu, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 8557

Identifier Type: OTHER

Identifier Source: secondary_id

16C.514

Identifier Type: -

Identifier Source: org_study_id