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

NCT01800838 | Completed Phase 1 Results DMC

• 3 other identifiers: CASE2411NCI-2013-000894130
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treatment (silicon phthalocyanine 4 and PDT)

EXPERIMENTAL

Patients receive silicon phthalocyanine 4 topically and then undergo PDT.

Drug: silicon phthalocyanine 4; Drug: photodynamic therapy; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

silicon phthalocyanine 4 DRUG

Given topically

Also known as: Pc 4, Pc-4 (Silicone phthalocyanine)

Treatment (silicon phthalocyanine 4 and PDT)

photodynamic therapy DRUG

Undergo PDT

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Treatment (silicon phthalocyanine 4 and PDT)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (silicon phthalocyanine 4 and PDT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (silicon phthalocyanine 4 and PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kevin Cooper MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

SUB1 protein, human; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Dr. Elma Baron
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

elma.baron@uhhospitals.org

216-368-4971

Study Officials

• Elma Baron, MD

  University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Chairman, Dermatology

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 16, 2019
• Results First Posted: May 16, 2019

Record last verified: 2019-05

Locations

US (1)