Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)

Inclusion Criteria

• Males or female ≥18 years of age at the time of study enrollment
• Have a clinical diagnosis of cutaneous T cell lymphoma CTCL, including documentation of a skin biopsy with histological findings consistent with CTCL (atypical epidermotrophic or folliculocentric T-cells). Unconfirmed diagnosis of CTCL must have a biopsy to confirm at screening
• Have Stage IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.
• Previous treatment with at least one standard therapy used to treat Stage IA, IB or IIA CTCL including but not limited to oral corticosteroids, high-potency topical corticosteroids, topical mechlorethamine, topical bexarotene, PUVA, UVB, total body electron beam radiation, biological response or oral methotrexate.
• Have measurable skin disease with at least 1 to 4 eligible baseline target lesions with a total area >25 cm2 but <100 cm2. Eligible lesions must be below the neck and may not involve the genitalia, intertriginous areas, internally, or to frankly ulcerated or infected skin.
• Generally healthy other than for CTCL, or with other stable diseases/conditions that are adequately controlled.
• Willing and able to provide written informed consent.
• Willing and able to adhere to the protocol requirements, including but not limited to study drug dosing, study drug visits, medication and treatment restrictions, and laboratory tests.
• Willing and able to discontinue concomitant medications or treatments for CTCL during the study.
• If a female of child bearing potential, willing to use adequate contraception (defined as double-method contraception, e.g. oral contraceptive usage by subject and condom by partner). Non-child bearing potential is defined as being at least 2 years post-menopausal or being surgically sterile.
• Willing to abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study.

Exclusion Criteria

• Have a known allergy to resiquimod or any of the excipients in the study drug.
• Stage IIB or greater CTCL.
• Require immediate treatment for progressive CTCL.
• Are unable to discontinue current treatment for CTCL due to risk of progression.
• Within 8 weeks of treatment initiation (Day 0), have received treatment with:
• Total body electron beam radiation
• Investigational drugs or treatments
• Within 4 weeks of treatment initiation (Day 0), have received treatment with:
• Local radiation therapy
• UVB therapy
• PUVA
• Any topical chemotherapy
• Photopheresis
• Systemic retinoids, corticosteroids, immune response modifiers including imiquimod, interferon inducers, chemotherapeutic agents, biologic agents including interferon
• Topical corticosteroids or retinoids
• Within 2 weeks of treatment initiation (Day 0), have received at or adjacent to the target treatment lesions.
• Any surgical procedures other than biopsies related to CTCL diagnosis or follow-up
• Any topical treatment other than bland moisturizers (creams, lotions, emollients, etc).
• Have other concurrent cutaneous conditions in the treatment area or immediately adjacent to the treatment area that would be exacerbated by resiquimod or interfere with assessments.
• Have a grade 2 or greater laboratory abnormalities (CTCAE v4) at baseline for any of the following:
• Hemoglobin
• White blood cell count
• Platelet count
• Alanine transferase
• Aspartate transferase
• Creatinine
• Have a known history of or a positive serologic test for infection with human immunodeficiency virus or human T lymphotrophic virus.
• Are pregnant or nursing, or intending to become pregnant within the duration of the study.
• Have any clinically significant medical conditions that are unstable, progressive, or inadequately controlled in the opinion of the investigator, that would pose a potential risk for the subject, result in poor compliance with the study requirements, or require treatment with an excluded medication or treatment during the study.
• Have an active che