This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells.
PRIMARY OBJECTIVES: I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF). SECONDARY OBJECTIVES: I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF. EXPLORATORY OBJECTIVES: I. To determine the quality of life during and after treatment. OUTLINE: Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks. After completion of study treatment, patients are followed up for up to 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given topically
Undergo PDT
Ancillary studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Complete clinical response
Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).
Time frame: At 24 weeks
Change in CAILS score
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Time frame: Baseline up to week 24
Change in field of treatment
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Time frame: Baseline up to week 24
Change in Skindex-16 score
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Time frame: Baseline up to week 24
Incidence of adverse events (AEs)
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
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Undergo RT
Time frame: Up to 2 years