Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides
Condition: Lymphoma
MeSH terms: Mycoses; Mycosis Fungoides
Intervention: TSEBT
Intervention description: Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage IB-IIIA Mycosis fungoides; Total Skin Electron Beam Therapy; TSEBT

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy-confirmed mycosis fungoides in stage IB-IIIA

          2. Patients must have failed or have been intolerant to at least one prior systemic or
             topical therapy which may include topical steroids

          3. 18 years of age or older

          4. Life expectancy greater than 6 months

          5. Eastern Cooperative Oncology Group (ECOG) of </= 2

          6. Adequate bone marrow function: White blood count (WBC) >/= 2000/uL; platelet count>/=
             100,000/mm3; Absolute neutrophil count (ANC) >/= 1000

          7. Required wash out period for prior therapies (Note: patients with progressive disease
             may be treated earlier than required washout period per Investigator's decision) a)
             Topical therapy: 2 weeks, b) Systemic biologic, monoclonal antibody or chemotherapy: 4
             weeks, c) Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks, d) Other
             investigational therapy: 4 weeks

          8. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if
             administered at least 4 weeks prior to initiation on study)

          2. Underlying medical condition including unstable cardiac disease, or other serious
             illness that would impair the ability of patient to undergo treatment

          3. Prior malignancy (active within 5 years of screening) except completely excised
             non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous
             cell carcinoma of the cervix

          4. Pregnant or lactating

          5. Initiation or change in dosage of topical corticosteroids within 3 weeks of study
             treatment (Note: topical steroid use within 3 weeks is allowed provided the strength
             and use has been stable for at least 1 month; 'prescription strength' topical
             corticosteroids cannot be started during the study)

          6. Any other medical history, including laboratory results, deemed by the Investigator to
             be likely to interfere with patient participation in the study