Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides

Not Recruiting

Trial ID: NCT00985140


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.

Official Title

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

Stanford Investigator(s)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)


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: WBC> 2000/uL; platelet count> 75,000/mm3; 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)

   - Topical therapy: 2 weeks

   - Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks

   - Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks

   - Other investigational therapy: 4 weeks

   8. Ability to understand and the willingness to sign a written informed consent

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


radiation: Total Skin Electron Beam Therapy (TSEBT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cameron Harrison

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