Clinical trial NCT05872854: Treatment of Mycosis Fungoides with Hypericin Ointment and Visible Light
Official title: Treatment of Mycosis Fungoides with Hypericin Ointment and Visible Light
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous T Cell Lymphoma
Mycosis Fungoides
Keywords: Cutaneous T Cell Lymphoma
Mycosis Fungoides
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Soligenix
First posted: 2023-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The goal of this clinical trial is to assess the benefit of continuous treatment with open label synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks).
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.

Detailed description: This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.

(Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.)

* Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
* Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study

Exclusion Criteria:

* History of allergy or hypersensitivity to any of the components of SGX301
* Pregnancy or mothers who are breast-feeding
* Males and females not willing to use effective contraception
* Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus, Sjogren's, etc.).
* Subjects whose condition is spontaneously improving.
* Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment
* Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
* Subjects who have received electron beam irradiation within 3 months of enrollment
* Subjects with a history of significant systemic immunosuppression
* Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
* Subject with any condition that, in the judgment of the PI, is likely to interfere with participation in the study
* Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.

Primary outcomes:
measure: Number of Treatment Responses of Index Lesions
timeFrame: Baseline up to 54 weeks
Secondary outcomes:
measure: The percent of patients achieving a Complete Response of All Lesions
timeFrame: Baseline up to 54 weeks
measure: The percent of patients achieving a PGA score of 3 (moderate improvement) from baseline to end of treatment.
timeFrame: Baseline up to 54 weeks
measure: The percent of patients achieving at least 50% change in the mSWAT (overall skin score) from baseline to end of treatment.
timeFrame: Baseline up to 54 weeks
measure: The percent of patients achieving at least 50% change in VASitch from baseline to end of treatment.
timeFrame: Baseline up to 54 weeks
measure: The change in CAILS score for each Index Lesion from baseline to end of treatment.
timeFrame: Baseline up to 54 weeks.
measure: The time needed to achieve at least a 50% change in the cumulative CAILS score of Index Lesions from baseline.
timeFrame: Baseline up to 54 weeks.
measure: The relative change in CAILS score for lesions classified as patch compared to plaque from baseline to end of treatment.
timeFrame: Baseline up to 54 weeks
measure: The time to maximal response in cumulative CAILS score.
timeFrame: Baseline up to 54 weeks
measure: The time to maximal response in cumulative PGA score.
timeFrame: Baseline up to 54 weeks
measure: The time to maximal response in cumulative mSWAT score.
timeFrame: Baseline up to 54 weeks
measure: The time to maximal response in cumulative VASitch score.
timeFrame: Baseline up to 54 weeks
measure: Change in Skindex-29 score at Week 12, Week 24, Week 36 and Week 54
timeFrame: Baseline up to 54 weeks
measure: Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54
timeFrame: Baseline up to 54 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
References: