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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03288818
Collaborator
Actelion (Industry)
0
Enrollment
1
Location
1
Arm
40
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mechlorethamine Hydrochloride Gel
  • Procedure: Total Skin Electron Beam Radiation Therapy
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to progression [Up to week 54]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University
    • Actelion

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03288818
    Other Study ID Numbers:
    • 16C.514
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Jan 29, 2018
    Last Verified:
    Jan 1, 2018
    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
    Additional relevant MeSH terms:
    Mycoses
    Mycosis Fungoides
    Mechlorethamine

    Study Results

    No Results Posted as of Jan 29, 2018