Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

Refractory Mycosis Fungoides Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides
• Refractory Mycosis Fungoides

• NCT number: NCT03281811
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Early Phase 1
• Start date: November 13, 2017
• Completion date: August 12, 2020