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

This study has been terminated.
(Competing studies)
Sponsor:
Information provided by (Responsible Party):
Richard T. Hoppe, Stanford University
ClinicalTrials.gov Identifier:
NCT00985140
First received: September 24, 2009
Last updated: May 4, 2017
Last verified: May 2017
  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.

Condition Intervention
Mycosis Fungoides Lymphomas: Non-Hodgkin Lymphomas: Non-Hodgkin Peripheral T-Cell Lymphomas: Non-Hodgkin Cutaneous Lymphoma Radiation: Total Skin Electron Beam Therapy (TSEBT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides

Resource links provided by NLM:


Further study details as provided by Richard T. Hoppe, Stanford University:

Primary Outcome Measures:
  • Clinical Response Rate [ Time Frame: 1 year ]

    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.



Biospecimen Retention:   Samples With DNA
2 x 5mm punch biopsies taken at enrollment and during follow up.

Enrollment: 13
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with mycosis fungoides refractory to at lest one prior treatment.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985140

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Richard T. Hoppe Stanford University
  More Information

Study Data/Documents: Peer reviewed article with pooled results.  This link exits the ClinicalTrials.gov site
This publication contains data from this study as well as two other clinical trials. Analysis was done on data pooled from the three trials.

Responsible Party: Richard T. Hoppe, Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology, Stanford University
ClinicalTrials.gov Identifier: NCT00985140     History of Changes
Other Study ID Numbers: IRB-16402
SU-09082009-3760 ( Other Identifier: Stanford University )
LYMNHL0072 ( Other Identifier: OnCore )
Study First Received: September 24, 2009
Results First Received: December 9, 2016
Last Updated: May 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on July 19, 2017