Skip to main content

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

General Information

Age Group

Adult

Status

Recruiting

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

For more information go to https://clinicaltrials.gov/ct2/show/NCT02448381