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

Kevin Cooper MD

Status and phase

Completed

Phase 1

Conditions

Stage I Cutaneous T-cell Non-Hodgkin Lymphoma

Stage IB Mycosis Fungoides/Sezary Syndrome

Recurrent Mycosis Fungoides/Sezary Syndrome

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Stage IIA Mycosis Fungoides/Sezary Syndrome

Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

Stage IA Mycosis Fungoides/Sezary Syndrome

Treatments

Drug: photodynamic therapy

Drug: silicon phthalocyanine 4

Other: laboratory biomarker analysis

Other: pharmacological study

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01800838

4130 (Other Identifier)

CASE2411

NCI-2013-00089 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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