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

Trial ID or NCT#

NCT00985140

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Biopsy-confirmed mycosis fungoides in stage IB-IIIA
  2. 2. Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
  3. 3. 18 years of age or older
  4. 4. Life expectancy greater than 6 months
  5. 5. Eastern Cooperative Oncology Group (ECOG) of \<= 2
  6. 6. Adequate bone marrow function: WBC\> 2000/uL; platelet count\> 75,000/mm3; ANC\> 1000
  7. 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)
    1. * 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. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
  1. 1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
  2. 2. Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
  3. 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. 4. Pregnant or lactating
  5. 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. 6. Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
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Investigator(s)

Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Contact us to find out if this trial is right for you.

Contact

Cameron Harrison
6507217186

View on ClinicalTrials.gov