Phase 2
N=4
Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01073267 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Objective Response Rate — .25 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TSEBT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
.25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Biopsy-confirmed mycosis fungoides in stage IB-IIIA
- 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 /= 2000/uL; platelet count>/= 100,000/mm3; Absolute neutrophil count (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) 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
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
- 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
Data sourced from ClinicalTrials.gov (NCT01073267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.