Clinical trial NCT00985140: Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides
Official title: A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mycosis Fungoides
Lymphomas: Non-Hodgkin
Lymphomas: Non-Hodgkin Peripheral T-Cell
Lymphomas: Non-Hodgkin Cutaneous Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with mycosis fungoides refractory to at lest one prior treatment.

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.

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 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

Primary outcomes:
measure: Clinical Response Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Richard T. Hoppe
role: PRINCIPAL_INVESTIGATOR
References: