- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881749
Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
August 29, 2016 updated by: Thomas Jefferson University
Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kelly Knoblauch
- Phone Number: (215) 955-9295
- Email: kelly.knoblauch@jefferson.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
August 24, 2016
First Submitted That Met QC Criteria
August 24, 2016
First Posted (Estimate)
August 29, 2016
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Lymphoma, T-Cell
- Mycoses
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Mechlorethamine
Other Study ID Numbers
- IRB #16C.514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sidney Kimmel Cancer Center at Thomas Jefferson...WithdrawnRecurrent Mycosis Fungoides and Sezary Syndrome | Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IIB Mycosis Fungoides and Sezary Syndrome | Stage IIIA Mycosis Fungoides and Sezary Syndrome | Stage IIIB Mycosis Fungoides and Sezary Syndrome | Stage IVA Mycosis Fungoides and Sezary Syndrome | Stage...
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Stanford UniversityTerminatedMycosis Fungoides | Lymphomas: Non-Hodgkin | Lymphomas: Non-Hodgkin Peripheral T-Cell | Lymphomas: Non-Hodgkin Cutaneous LymphomaUnited States
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Stanford UniversityRecruitingMycosis Fungoides | Sezary SyndromeUnited States
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Assistance Publique - Hôpitaux de ParisNot yet recruitingMycosis Fungoides | Cutaneous T Cell Lymphoma
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