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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT01073267

Run by

M.D. Anderson Cancer Center

People needed

4

Starts

2010-02-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-confirmed mycosis fungoides in stage IB-IIIA
• Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
• 18 years of age or older
• Life expectancy greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) of </= 2
• Adequate bone marrow function: White blood count (WBC) >/= 2000/uL; platelet count>/= 100,000/mm3; Absolute neutrophil count (ANC) >/= 1000
• 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
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
• Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
• 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
• Pregnant or lactating
• 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)
• Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.