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

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ClinicalTrials.gov Identifier: NCT01073267
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lymphoma Radiation: TSEBT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
Study Start Date : February 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TSEBT
Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy
Radiation: TSEBT
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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073267

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Bouthaina Dabaja, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01073267    
Other Study ID Numbers: 2009-0444
NCI-2011-00560 ( Registry Identifier: NCI CTRP )
First Posted: February 23, 2010    Key Record Dates
Results First Posted: December 31, 2015
Last Update Posted: December 31, 2015
Last Verified: November 2015
Keywords provided by M.D. Anderson Cancer Center:
Stage IB-IIIA Mycosis fungoides
Total Skin Electron Beam Therapy
Additional relevant MeSH terms:
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Mycosis Fungoides
Bacterial Infections and Mycoses
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases