Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides

2014-08-27 03:15:43 | BioPortfolio


The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.

Primary Objective:

To determine clinical response rate to total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy) in subjects with stage IB-IIIA mycosis fungoides (MF).

Secondary Objectives:

1. To determine duration of response and time to progression following course of TSEBT 12 Gy.

2. To determine pruritus response

3. To evaluate safety and tolerability of TSEBT 12Gy.


Study Radiation:

During total skin electron beam therapy, radiation is given to the entire surface of the skin. This may cause the cancer cells to die.

Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.

Screening Period:

You will have the following "screening tests" to help the doctor decide if you are eligible to take part in this study.

Within 6 weeks before the radiation therapy can begin:

- If the doctor thinks it is needed, you will have a computed tomography (CT) scan or other type of scan to check the status of the disease.

- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for cancer in your lymph nodes.

Within 4 weeks before the radiation therapy can begin:

- Your medical history will be recorded, including any drugs you are taking and have taken.

- You will have a physical exam, including a skin exam and measurement of your weight and vital signs (blood pressure, heart rate, temperature, and breathing rate).

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- Blood (about 1 teaspoon) will be drawn for routine tests.

- Women who are able to become pregnant must have a negative urine pregnancy test.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Wash-Out Period:

If you agree to take part in this study, from that day until your first study radiation treatment, you will stop certain treatments for mycosis fungoides. This is called a "wash-out period". The number of weeks will be different depending on what treatments you may be receiving. The study doctor will explain the types of treatments and schedule for stopping them.

- For the 2 weeks before radiation, you will stop using any cancer drugs that are "topical" (applied onto the skin).

- For the 4 weeks before radiation, you will stop any radiation therapy, phototherapy (cancer treatments with light), cancer drugs that are "systemic" (affecting the whole body), and any other investigational therapy.

Study Visit Before Radiation Therapy:

Within 5 days before your first radiation treatment, the following tests and procedures will be performed:

- You will have a physical exam, including a skin exam and measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking.

- The doctor will draw on your skin with a marker to mark areas of your body that are unexposed. This is to help plan the radiation treatments. Depending on your body shape, about 8-16 body areas will be marked.

- Photos will be taken of your whole body. These photos will be used to help the doctor find out how much skin is affected by the disease.

Radiation Treatments:

If you are found to be eligible to take part in this study, you will receive low-dose radiation to the skin 4-5 days a week for 3 weeks.

On Mondays and Tuesdays, you will receive radiation that can cover your entire skin area. You will be standing during the treatment. This wider-field radiation treatment cannot give enough radiation to the unexposed areas of your body, such as under the arms, under the breasts for females, under the belly, in the private areas, and the soles of the feet. For this reason, in addition to the wider-field radiation, you will also receive radiation that covers these smaller areas of your body on Wednesdays and Thursdays. The amount of radiation that these smaller body areas will receive is designed to be the same as the amount the rest of the skin will receive.

If the study doctor thinks it is needed for standard care, you will also receive radiation treatments on other tumors. In most cases, this will be on Fridays. It will be 4-7 treatments, depending on the tumor size.

At Weeks 2 and 3 of radiation treatment, you will be asked about any side effects that have occurred.

Length of Study:

You may receive up to 3 weeks of low-dose radiation therapy. You will be taken off the study treatment early if intolerable side effects occur or the disease gets worse. The follow-up period in this study lasts up to 12 months after the last treatment.

Follow-Up and End-of-Study Visits:

After your last dose of low-dose radiation therapy, you will have follow-up visits once a month for 6 months, and then every 2 months for the next 6 months. However, if the disease gets worse during this 12-month follow-up period, the follow-up visits will stop. When you are off-study, an end-of-study visit will occur.

If you stopped the radiation early due to intolerable side effects, you will have follow-up visits twice a week until the doctor thinks the side effects have gotten better. After that, you will return for an end-of-study visit.

At the follow-up visits and end-of-study visit, the following tests and procedures will be performed:

- You will have a physical exam, including a skin exam and measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and side effects that may have occurred.

- Photos will be taken of your whole body to check the status of the disease.

This is an investigational study. For this type of cancer, the dose of radiation in this study is lower than standard. The type of radiation therapy (total skin electron beam therapy) is standard. At this time, the lower dose is only being used in research.

Up to 20 patients will be take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment






UT MD Anderson Cancer Center
United States




M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:43-0400

Clinical Trials [1605 Associated Clinical Trials listed on BioPortfolio]

NM-IL-12 in Cutaneous T-Cell Lymphoma (CTCL) Undergoing Total Skin Electron Beam Therapy (TSEBT)

In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose TSEBT ther...

Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome

Hypothesis: Addition of low dose TSEBT to debulk MF/SS either before or during checkpoint blockade with anti-PD-1 pembrolizumab monoclonal antibody therapy will be safe and well tolerated....

Phase II Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides

To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA.

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-cel...

A Study for Patients With Non-Hodgkin's Lymphomas

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and A...

PubMed Articles [899 Associated PubMed Articles listed on BioPortfolio]

Impact of comorbidity on disease characteristics, treatment intent and outcome in diffuse large B-cell lymphoma - a Swedish lymphoma register study.

Comorbidity impacts overall survival among patients with diffuse large B-cell lymphoma (DLBCL). However, associations of comorbidity with lymphoma characteristics, treatment selection and lymphoma-spe...

Primary Cutaneous Follicle Center Lymphoma.

Primary cutaneous follicle center lymphoma is a low-grade B-cell lymphoma that is limited to the skin at diagnosis. It has a differential diagnosis that includes systemic/nodal follicular lymphoma sec...

Spectrum of lymphoma in Bahrain. A retrospective analysis according to the World Health Organization classification.

To determine the spectrum of various types of lymphoma in Bahrain according to the latest World Health Organization classification criteria.  Methods: A retrospective review was conducted for all ne...

Aggressive B cell lymphomas in the 2017 revised WHO classification of tumors of hematopoietic and lymphoid tissues.

The recent 2017 update of the World Health Organization classification of lymphomas has significant changes from the previous edition. Subtypes of large B cell lymphoma and related aggressive B cell l...

Lymphoma in autopsy cases.

Lymphoproliferative disorders cause significant morbidity and mortality, either related to the disease itself or therapy complications. Some cases of lymphoma may have vague clinical presentation, esp...

Medical and Biotech [MESH] Definitions

A leukemia/lymphoma found predominately in children and young adults and characterized LYMPHADENOPATHY and THYMUS GLAND involvement. It most frequently presents as a lymphoma, but a leukemic progression in the bone marrow is common.

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

A form of undifferentiated malignant LYMPHOMA usually found in central Africa, but also reported in other parts of the world. It is commonly manifested as a large osteolytic lesion in the jaw or as an abdominal mass. B-cell antigens are expressed on the immature cells that make up the tumor in virtually all cases of Burkitt lymphoma. The Epstein-Barr virus (HERPESVIRUS 4, HUMAN) has been isolated from Burkitt lymphoma cases in Africa and it is implicated as the causative agent in these cases; however, most non-African cases are EBV-negative.

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

More From BioPortfolio on "Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides"

Quick Search


Relevant Topics

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Searches Linking to this Trial