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

Primary Purpose

Mycosis Fungoides

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mechlorethamine Hydrochloride Gel
Total Skin Electron Beam Radiation Therapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycosis Fungoides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low dose TSEBT, mechlorethamine hydrochloride gel

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2017
Last Updated
January 25, 2018
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT03288818
Brief Title
Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides
Official Title
IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding discontinued
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Actelion

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose TSEBT, mechlorethamine hydrochloride gel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mechlorethamine Hydrochloride Gel
Other Intervention Name(s)
Valchlor
Intervention Description
Given topically
Intervention Type
Procedure
Intervention Name(s)
Total Skin Electron Beam Radiation Therapy
Other Intervention Name(s)
TSEB radiation therapy
Intervention Description
Undergo low dose (TSEBT) Total Skin Electron Beam Therapy
Primary Outcome Measure Information:
Title
Time to progression
Description
Will be evaluated using the Kaplan-Meier estimator of the survival curves.
Time Frame
Up to week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joya Sahu, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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