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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given topically
Undergo PDT
Correlative studies
Correlative studies
University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MTD of Photodynamic Therapy
Defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to 30 days
MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 30 days
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