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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides

Brief Summary: 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.

Detailed Summary:

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:

Signing this consent form does not mean that you will be able to take part in this study. 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 rou
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Objective Response Rate [ Time Frame: Baseline and at least 2 months ]

    Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).

    Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score.



    Original Primary Outcome: Objective Response Rate [ Time Frame: Baseline and at least 2 months ]

    Objective response rate defined as the proportion of patients achieving CCR and PR (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: February 19, 2010
    Date Started: February 2010
    Date Completion:
    Last Updated: November 25, 2015
    Last Verified: November 2015