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

Primary Purpose

Mycosis Fungoides, Cutaneous T-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Total skin electron beam therapy (TSEBT)

mechlorethamine gel 0.016%

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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TSEBT & mechlorethamine gel 0.016%

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to progression

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

Response rate (CR and PR)

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).

Full Information

NCT ID

NCT02881749

First Posted

August 24, 2016

Last Updated

August 29, 2016

Sponsor

Thomas Jefferson University

Collaborators

Actelion

1. Study Identification

Unique Protocol Identification Number

NCT02881749

Brief Title

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

Official Title

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

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

Actelion

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

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

Mycosis Fungoides, Cutaneous T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TSEBT & mechlorethamine gel 0.016%

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Total skin electron beam therapy (TSEBT)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

mechlorethamine gel 0.016%

Other Intervention Name(s)

Valchlor

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to progression

Description

To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.

Time Frame

One year

Secondary Outcome Measure Information:

Title

Response rate (CR and PR)

Description

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly Knoblauch

Phone

(215) 955-9295

kelly.knoblauch@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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

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