Overview
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.
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
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.