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

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

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: pharmacological study; Drug: silicon phthalocyanine 4; Drug: photodynamic therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with early stage MF (CTCL stage IA-IIA)
• Has at least 2 evaluable plaques
• Has been off systemic therapies for at least 4 weeks
• Has been off topical therapies for at least 2 weeks
• Has been off phototherapies for at least 2 weeks
• All skin photo-types will be included
• Subjects must have the ability to understand and the willingness to sign a written informed consent form
• Women of child-bearing potential must agree to utilize a birth control which results in a failure rate of less that 1% per year during the study; accepted forms of birth control for this study include: injections such as Depo-Provera and Lunelle, implants such as Norplant, and intra-uterine devices
• Sexually active males must agree to use a medically acceptable form of birth control for the duration of the study and for at least 3 months after the last dose of the study medication; appropriate birth control methods are using a condom with a spermicide or surgical sterilization

Exclusion Criteria:

• Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
• Any medical condition that could be aggravated or may cause extreme discomfort during the study period
• Lesions only on the face, scalp or other sites that would make biopsies not cosmetically acceptable
• Women of childbearing potential who are pregnant or attempting to become pregnant are excluded from this study
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to silicon phthalocyanine (Pc 4) or other agents used in this study
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (silicon phthalocyanine 4 and PDT); Patients receive silicon phthalocyanine 4 topically and then undergo PDT.	Other: laboratory biomarker analysis; Correlative studies; Other: pharmacological study; Correlative studies; Other Names: pharmacological studies; Drug: silicon phthalocyanine 4; Given topically; Other Names: Pc 4; Pc-4 (Silicone phthalocyanine); Drug: photodynamic therapy; Undergo PDT; Other Names: PDT; Light Infusion Therapy™; therapy, photodynamic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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		Up to 30 days

Collaborators and Investigators

• Sponsor: Kevin Cooper MD
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elma Baron, MD, University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Disease; Bacterial Infections and Mycoses; Lymphoma; Syndrome; Recurrence; Lymphoma, Non-Hodgkin; Mycoses; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Photosensitizing Agents; Dermatologic Agents; Trace Elements; Micronutrients; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Silicon; Silicon phthalocyanine
• Other Study ID Numbers: CASE2411; NCI-2013-00089 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 4130 (Other Identifier: Orphan Product grant number)