Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Stage IA Mycosis Fungoides/Sezary Syndrome, Stage IB Mycosis Fungoides/Sezary Syndrome, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIA Mycosis Fungoides/Sezary Syndrome, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Conditions
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
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.
Interventions
Given topically
DRUGphotodynamic therapy
Undergo PDT
OTHERpharmacological study
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Kevin Cooper MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD of Photodynamic Therapy | Up to 30 days | 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. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
This study recruited patients between April 2013 and April 2015 at Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Participants by arm
| Arm | Count |
|---|---|
| Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2) Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies | 1 |
| Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2) Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 100J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies | 1 |
| Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2) Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 150J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies | 7 |
| Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2) Patients receive 0.5mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies | 2 |
| Total | 11 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Continuous | 63 years | 61 years | 51 years | 49 years | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 7 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Distribution FST I | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Fitzpatrick Skin Type Distribution FST II | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Fitzpatrick Skin Type Distribution FST III | 1 participants | 1 participants | 3 participants | 1 participants | 6 participants |
| Fitzpatrick Skin Type Distribution FST IV | 0 participants | 0 participants | 1 participants | 1 participants | 2 participants |
| Fitzpatrick Skin Type Distribution FST V | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Fitzpatrick Skin Type Distribution FST VI | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 6 Participants | 2 Participants | 10 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 7 participants | 2 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 6 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Silicon Phthalocyanine 4 and PDT) | MTD of Photodynamic Therapy | 150 J/cm^2 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 mg/ml |