Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Cutaneous Lymphoma, Lymphomas: Non-Hodgkin Peripheral T-Cell, Mycosis Fungoides
Conditions
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.
Interventions
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.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 strengthtopical 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response Rate | 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. |
Countries
United States
Participant flow
Recruitment details
Patients who may be eligible for the trial will be approached by the Investigator and offered participation in the trial. During a clinic visit, the Investigator or co-Investigator will explain the study to the potential subject verbally, and will allow the potential subject ample opportunity to ask questions.
Pre-assignment details
Patients will undergo the following procedures during the screening period: Medical Hx, H&P, Severity Weighted Assessment Tool (mSWAT) assessment, simulation/set-up for TSEBT, CT if needed, pruritus, hair, and nail assessment, standardized photos (global, nails, head: top, front, sides, back), and two 5 mm punch biopsies from an active MF lesion.
Participants by arm
| Arm | Count |
|---|---|
| 12 Gy TSEBT 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. Discrete tumors may receive additional boost treatment not to exceed 12 Gy. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | 12 Gy TSEBT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 61.4 years STANDARD_DEVIATION 15.2 |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
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.
Time frame: 1 year
Population: All patients who completed treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12 Gy TSEBT | Clinical Response Rate | Partial Response | 11 participants |
| 12 Gy TSEBT | Clinical Response Rate | Stable disease | 2 participants |