NCT03281811

Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid Hydrochloride	Given topically
DRUG	Photodynamic Therapy	Undergo PDT
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Radiation Therapy	Undergo RT

Timeline

• Start date: 2017-11-13
• Primary completion: 2020-02-25
• Completion: 2020-08-12
• First posted: 2017-09-13
• Last updated: 2023-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study