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Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides

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ClinicalTrials.gov Identifier: NCT02881749
Recruitment Status : Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Cutaneous T-cell Lymphoma Radiation: Total skin electron beam therapy (TSEBT) Drug: mechlorethamine gel 0.016% Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
Study Start Date : September 2016
Estimated Primary Completion Date : August 2020


Arm Intervention/treatment
Experimental: TSEBT & mechlorethamine gel 0.016%
All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT.
Radiation: Total skin electron beam therapy (TSEBT)
TSEBT will be given in 6 fractions at 2 Gy per fraction every Monday, Wednesday, and Friday over the course of 2 weeks (total TSEBT dosage is 12 Gy). Supplements up to 8 Gy will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions, scalp, etc. Discrete tumors may receive additional "boost" up to 8 Gy.

Drug: mechlorethamine gel 0.016%
The maintenance period for this study includes one year of weekly mechlorethamine gel 0.016%. This period will not begin until the observation period (30 days) has been completed. During the first week of the maintenance period, patients will apply mechlorethamine gel to the entire body surface daily. After the first week, patients will apply mechlorethamine gel to entire body surface one time per week for the rest of the maintenance period.
Other Name: Valchlor




Primary Outcome Measures :
  1. Time to progression [ Time Frame: One year ]
    To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.


Secondary Outcome Measures :
  1. Response rate (CR and PR) [ Time Frame: One year ]
    To assess the response rate (CR and PR) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen. . CR and PR are defined as the standard oncology criteria for complete response (100% reduction from the baseline score) and partial response (50% to <100% reduction from the baseline score).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male or Female
  • ≥ 18 years of age
  • 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
  • Eligible, in the opinion of the investigator, for low dose TSEBT over the course of two weeks.
  • 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.
  • Patients who do not have their disease downgrade to stage IA or IB 30 days following low dose 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
  • Decisionally-impaired individuals, prisoners, and vulnerable populations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881749


Contacts
Contact: Kelly Knoblauch (215) 955-9295 kelly.knoblauch@jefferson.edu

Sponsors and Collaborators
Thomas Jefferson University
Actelion

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02881749     History of Changes
Other Study ID Numbers: IRB #16C.514
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mechlorethamine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents