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Melanoma / Skin
General Information
Study Name:
A Phase III Multicenter Randomized Placebo Controlled Study to Determine the Efficacy of Topical SGX301 and Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
Age Group:
Adult
Protocol Number:
NCT02448381
Background Information:
The study will to evaluate the efficacy and safety of SGX301 in an ointment at a concentration of 0.25%, applied twice weekly for six weeks, under occlusion for 16-24 hours followed by the administration of visible light up to a dose of 8 joules/cm2 twice weekly for each of three 6-week cycles. The initial cycle compared to a placebo ointment applied for the first treatment cycle. A minimum of 3 and a maximum of 5 lesions will be identified and indexed for treatment and evaluation. In order to ensure that the CAILS assessment is based on the same number of lesions for each patient, the investigator (prior to randomization) will select 3 of the lesions in each patient for primary evaluation in the first two cycles of treatment.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Adult male and/or female subjects between the ages of 18 and 70 years
Subjects with a clinical diagnosis of cutaneous T-cell (CTCL, mycosis fungoides), Stage IA, Stage IB, or Stage IIA
Subjects with a minimum of three (3) evaluable, discrete lesions
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 30 days of treatment initiation
Subjects willing to refrain from sunbathing for the duration of the study
Additional eligibility in protocol
Ineligibility Information
History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren’s syndrome, xeroderma pigmentosum, and melanoma and polymorphous light or radiation therapy within 30 days of enrolling
History of allergy to or hypersensitivity to cosmetics, toiletries or other dermatological products
Pregnancy or mothers who are breast feeding
Males and females not willing to use effective contraception
Unhealed sunburn
Subjects receiving systemic or topical steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
Subjects who have received electron beam irradiation within the potential treatment field within 3 months of enrollment
Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV
Additional ineligibility in protocol
Contact Information
Contact Name:
Kelly Jeffords, CCRP
Contact Phone:
571-472-0631
Contact Email:
kelly.jeffords@inova.org
For more information go to
https://clinicaltrials.gov/ct2/show/NCT02448381