NCT01800838

Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma

Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures

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

Summary

This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma. Funding Source - FDA OOPD

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an accelerated dose escalation protocol consisting of a single exposure to PDT using topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I) II. Determine safety and tolerability of repeated light (PDT) exposures after a single application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort II) III. Identification of targets for assessment of efficacy to assist in planning for a Phase II study. OUTLINE: This is a dose-escalation study. Patients receive silicon phthalocyanine 4 topically and then undergo PDT. After completion of study treatment, patients are followed up at 24 hours, 1 week, 2 weeks, and 30 days.

Conditions

• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IA Mycosis Fungoides/Sezary Syndrome
• Stage IB Mycosis Fungoides/Sezary Syndrome
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IIA Mycosis Fungoides/Sezary Syndrome

Interventions

Type	Name	Description
DRUG	silicon phthalocyanine 4	Given topically
DRUG	photodynamic therapy	Undergo PDT
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-09-01
• Completion: 2015-05-01
• First posted: 2013-02-28
• Last updated: 2019-05-16
• Results posted: 2019-05-16

Locations

1 site across 1 country: United States