Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
Condition: Neoplastic Syndrome
MeSH terms: Basal Cell Nevus Syndrome; Neoplasms; Syndrome
Intervention: tazarotene
Intervention description: Tazarotene is a member of the acetylenic class of retinoids.
Intervention MeSH terms: Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: nevoid basal cell carcinoma syndrome; basal cell carcinoma of the skin

Summary:

      RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in
      treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
    

Eligibility criteria:

        List of Inclusion Criteria:

          1. Study subjects must have at least one basal cell carcinoma ≥ 3mm in diameter (target
             lesion) on any area of the skin except the face, chest, and back (and not impinging on
             vital sites) diagnosed clinically by a Study Investigator at the baseline visit.

          2. Study subjects must meet diagnostic criteria for basal cell nevus syndrome including
             major criterion #1 plus one additional major criterion or two of the minor criteria
             outlined in Table I. A first degree relative would satisfy BCNS diagnostic criteria
             with any two major criteria or any single major plus two minor criteria.

        Table I. BCNS Diagnostic Criteria

        Major criteria

          1. More than 2 BCCs or one under the age of 20 years

          2. Odontogenic keratocysts of the jaw proven by histology

          3. Three or more palmar and/or plantar pits

          4. Bilamellar calcification of the falx cerebri (if less than 20 years old)

          5. Fused, bifid, or markedly splayed ribs.

          6. First degree relative with basal cell nevus syndrome (BCNS)

          7. PTCH1 gene mutation in normal tissue*

        Minor criteria

          1. Macrocephaly determined after adjustment for height

          2. Congenital malformations: cleft lip or palate, frontal bossing, "coarse face."

          3. Skeletal abnormalities: Sprengel deformity, marked pectus deformity

          4. Radiological abnormalities: bridging of the sella turcica, vertebral anomalies such as
             hemivertebrae, fusion or elongation of the vertebral bodies.

          5. Ovarian fibroma

          6. Medulloblastoma

        3.The subject is from 18-75 years of age, inclusive.

        4. If the subject is female and of child-bearing potential (women are considered not of
        childbearing potential if they are at least 2 years post-menopausal and/or surgically
        sterile), she:

        i. has been using adequate contraception (abstinence, IUD, birth control pills, or
        spermicidal gel with diaphragm or condom) since her last menses and will use adequate
        contraception during the study, and ii. is not lactating, and iii. has documented one
        negative serum pregnancy test within 14 days prior to study entry.

        5. The subject is willing to abstain from application of non-study topical medications to
        the skin of the face for the duration of the study, including prescription and over the
        counter preparations.

        6. The subject is willing not to have targeted BCCs treated by their PSCP unless the BCCs
        are documented by Study Investigators, preferably on two separate visits, except when the
        PSCP believes that delay in treatment potentially might compromise the health of the
        subject.

        List of Exclusion Criteria:

          1. The subject has used topical or systemic therapies that might interfere with the
             evaluation of the study medication during the study.

          2. The subject has a history of hypersensitivity to any of the ingredients in the study
             medication formulations.

          3. The subject is unable to return for follow-up tests.

          4. The subject has uncontrolled systemic disease, including known HIV positive patients.

          5. The subject has a history of other skin conditions or significant illness that would
             interfere with evaluation of the study medication.

          6. Any condition or situation which in the Investigator's opinion may put the subject at
             significant risk, could confound the study results, or could interfere significantly
             with the subject's participation in the study.

          7. The subject has a history of invasive cancer within the past five years excluding
             non-melanoma skin cancer, Stage I cervical cancer, or CLL Stage 0.