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

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

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.

Study Overview

• Status: Terminated
• Conditions: Mycosis Fungoides; Lymphomas: Non-Hodgkin; Lymphomas: Non-Hodgkin Peripheral T-Cell; Lymphomas: Non-Hodgkin Cutaneous Lymphoma
• Intervention / Treatment: Radiation: Total Skin Electron Beam Therapy (TSEBT)

Detailed Description

Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Supplements will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions (1-2 Gy fractions to a total dose of 12 Gy). Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. During the course of TSEBT patients will be evaluated weekly in the Department of Radiation Oncology for determination of adverse events and toxicity grading according the NCI Common Toxicity Criteria (CTC) Version 3.0.

A baseline evaluation will occur on the first day of TSEBT at which time the following procedures will be performed: (This visit may be waived if TSEBT is initiated within one week of the screening visit AND there is no clinical evidence of disease progression). After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks , and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. Patients who withdraw during the treatment period due to intolerance to radiotherapy will be followed weekly until toxicities have reverted to Grade ≤ 2 or has stabilized in the opinion of the Investigator, at which point a final visit will be scheduled. A final visit should be attempted for all patients who are lost to follow-up.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with mycosis fungoides refractory to at lest one prior treatment.

Description

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 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
12 Gy TSEBT; Prospective assignment to receive 12 Gy total skin electron beam therapy (TSEBT) for mycosis fungoides	Radiation: Total Skin Electron Beam Therapy (TSEBT); The purpose of the study is to examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gray) in patients who have mycosis fungoides (MF) staged as IB to IIIB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response Rate	After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease.	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Richard T. Hoppe, Stanford University

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 24, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Lymphoma, T-Cell; Lymphoma; Mycoses; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides
• Other Study ID Numbers: IRB-16402; SU-09082009-3760 (Other Identifier: Stanford University); LYMNHL0072 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Study Data/Documents

1. Peer reviewed article with pooled results.
   Information comments: This publication contains data from this study as well as two other clinical trials. Analysis was done on data pooled from the three trials.