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

Mycosis Fungoides Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00985140
• Other study ID #: LYMNHL0072
• Secondary ID: SU-09082009-3760
• Status: Terminated
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: May 24, 2012
• Start date: June 2009
• Est. completion date: December 2015

Study information

• Verified date: May 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Outcome Time Frame:		monthly	Yes