CompletedNCT01800838Updated May 16, 2019Results posted

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

A Phase 1 interventional study of silicon phthalocyanine 4 and photodynamic therapy in Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome and Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, sponsored by Kevin Cooper MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Kevin Cooper MD · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 11
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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

Read the 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 studied

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

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In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 11 is below the median of 46 across 358 interventional studies indexed under Mycoses.

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Lead sponsor

This is the only study on the registry with Kevin Cooper MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 11 participants (actual)

Study arms

Experimental
Treatment (silicon phthalocyanine 4 and PDT)
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

Drugsilicon phthalocyanine 4
Given topically
Also known as: Pc 4, Pc-4 (Silicone phthalocyanine)
Drugphotodynamic therapy
Undergo PDT
Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic
Otherpharmacological study
Correlative studies
Also known as: pharmacological studies
Otherlaboratory biomarker analysis
Correlative studies

What researchers measure

Primary outcomes

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

Results

Posted May 16, 2019

Participant flow

This study recruited patients between April 2013 and April 2015 at Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participant flow — Overall Study
Milestone	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100J/cm2)	Pc4 0.1(mg/ml) and Fluence 150(J/cm2)	Pc4 0.5(mg/ml) and Fluence 50(J/cm2)
Started	1	1	7	2
Completed	1	1	7	2
Not completed	0	0	0	0

Outcome measures

PrimaryMTD 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
Reported as:: Number · J/cm^2

MTD of Photodynamic Therapy
J/cm^2	Treatment (Silicon Phthalocyanine 4 and PDT)
MTD of Photodynamic Therapy	150

PrimaryMTD 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
Reported as:: Number · mg/ml

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
mg/ml	Treatment (Silicon Phthalocyanine 4 and PDT)
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	0.1

Adverse events

Collected over Patients will be followed for 30 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment (Silicon Phthalocyanine 4 and PDT)	—	0/11 (0%)	11/11 (100%)

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Treatment (Silicon Phthalocyanine 4 and PDT)
PainInjury, poisoning and procedural complications	11/11
pruritusSkin and subcutaneous tissue disorders	2/11
ItchingSkin and subcutaneous tissue disorders	2/11
Elevated creatinineInvestigations	2/11
Superficial ulcerationSkin and subcutaneous tissue disorders	2/11
Peeling SkinSkin and subcutaneous tissue disorders	1/11
Cracked ToothGastrointestinal disorders	1/11
Atrial fibrillationCardiac disorders	1/11
Sutures RemovedInjury, poisoning and procedural complications	1/11
HypertensionVascular disorders	1/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
Median	63 (63 to 63)	61 (61 to 61)	51 (42 to 73)	49 (41 to 57)	55 (41 to 73)

Sex: Female, Male
Sex: Female, Male(Participants)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
Female	0	0	1	1	2
Male	1	1	6	1	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	1	1	7	2	11
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	1	0	1
White	1	1	6	2	10
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
United States	1	1	7	2	11

Fitzpatrick Skin Type Distribution
Fitzpatrick Skin Type Distribution(participants)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)	Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)	Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)	Total
FST I	0	0	2	0	2
FST II	0	0	1	0	1
FST III	1	1	3	1	6
FST IV	0	0	1	1	2
FST V	0	0	0	0	0
FST VI	0	0	0	0	0

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01800838
Lead sponsor: Kevin Cooper MD
Collaborators: National Cancer Institute (NCI)
Responsible party: Kevin Cooper MD (Department Chairman, Dermatology, Case Comprehensive Cancer Center) — Sponsor-investigator
First posted: Feb 28, 2013
Start date: Apr 2013
Primary completion: Sep 2014
Completion: May 2015
Results posted: May 16, 2019
Last update: May 16, 2019

Study contacts

Elma Baron, MD

principal investigator · University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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