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

NCT00985140 | Terminated Results DMC

• 3 other identifiers: IRB-16402SU-09082009-3760LYMNHL0072
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mycosis Fungoides; Lymphomas: Non-Hodgkin; Lymphomas: Non-Hodgkin Peripheral T-Cell; Lymphomas: Non-Hodgkin Cutaneous Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Total Skin Electron Beam Therapy (TSEBT) RADIATION

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.

12 Gy TSEBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
• \. 18 years of age or older
• \. Life expectancy greater than 6 months
• \. Eastern Cooperative Oncology Group (ECOG) of \<= 2
• \. Adequate bone marrow function: WBC\> 2000/uL; platelet count\> 75,000/mm3; ANC\> 1000
• \. 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
• \. Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• \. Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
• \. 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
• \. Pregnant or lactating
• \. 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)
• \. Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 x 5mm punch biopsies taken at enrollment and during follow up.

MeSH Terms

Conditions

Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Richard T. Hoppe, MD Henry S. Kaplan Harry Lebeson Professor of Cancer Biology
• Organization: Stanford University Cancer Center

hoppe@stanford.edu

(650) 723-5510

Study Officials

• Richard T. Hoppe

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 2, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)