Phase
Condition
Cutaneous T-cell Lymphoma
Lymphoproliferative Disorders
Mycosis Fungoides
Treatment
Hypericin
Visible Light
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosisfungoides), 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 writteninformed consent
Female subjects not pregnant nor nursing and willing to undergo a pregnancy testwithin 21 days prior to treatment initiation and agree to use a medically acceptedmethod of birth control such as oral contraceptives (birth control pill), Barriermethod (condom plus spermicide or diaphragm plus spermicide) or abstaining fromintercourse while on study
Exclusion
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., nitrogenmustard) on lesions for CTCL within 2 weeks of enrollment
Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrowband UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies forCTCL 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 ofenrollment
Subject with any condition that, in the judgment of the PI, is likely to interferewith participation in the study
Subjects receiving drugs known to cause photosensitization within 2 weeks ofstarting SGX301 therapy unless they have not had evidence of photosensitizationafter receiving a stable dose of the medication for a minimum of 4 weeks.
Study Design
Study Description
Connect with a study center
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19034
United StatesActive - Recruiting
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