An Early Phase 1 interventional study of Aminolevulinic Acid Hydrochloride and Photodynamic Therapy in Refractory Mycosis Fungoides, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Treatment
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.
Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to 4 lesions in a single field of PDT or RT will be considered for treatment):
Exclusion Criteria:
Women of childbearing potential (post-menopausal or not of child-bearing potential) is defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:
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.
Drug: Aminolevulinic Acid Hydrochloride · Drug: Photodynamic Therapy · Other: Quality-of-Life Assessment · Radiation: Radiation Therapy
Given topically
Also known as: .delta.-Aminolevulinic acid hydrochloride, Alacare, Ameluz, Aminolevulinic Acid HCl, Delta-Aminolevulinic Acid HCl, Delta-Aminolevulinic Acid Hydrochloride, Levulan, Levulan Kerastick
Undergo PDT
Also known as: PDT, Photoradiation Therapy
Ancillary studies
Also known as: Quality of Life Assessment
Undergo RT
Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
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.
Time frame: Up to 2 years
Patient-reported outcomes
Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms, as well as with clinical outcomes (response) and clinician-assessed symptoms (National Cancer Institute \[NCI\] CTCAE v4).
Time frame: Up to 2 years
Quality of life (QOL)
Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes (response) and clinician-assessed symptoms (NCI CTCAE v4).
Time frame: Up to 2 years
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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