Trial Search Results

Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

This phase II trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kavita Sarin

Stanford Investigator(s):

Intervention(s):

  • Drug: Enzyme Inhibitor Therapy
  • Other: Laboratory Biomarker Analysis

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Must have at least one BCC lesion > 1 cm (BCC > 10 mm) in non-cosmetically sensitive
   site(s)

   - Must be willing to apply the topical remetinostat 3 times daily for 8 weeks

   - For women of child bearing potential, a negative urine pregnancy test

   - Women of child bearing potential are expected to use an effective method of birth
   control while participating in the study and for 1 month after applying the last dose

   - For male subjects with female partners of childbearing potential, agreement to use
   adequate contraception while participating in the study and for 1 month after applying
   the last dose

   - Has signed and dated the current Institutional Review Board (IRB) approved informed
   consent document

Exclusion Criteria:

   - Taking any medication known to interact with histone deacetylase (HDAC) inhibitors,
   such as valproate or anticoagulants

   - Taking any medication known to affect hedgehog (HH) signaling pathway such as
   itraconazole

   - Within the past 6 months, has used topical or systemic therapies that might interfere
   with the evaluation of the study medication during the study; specifically, these
   include the topical use to the study tumors of:

      - Glucocorticoids

      - Retinoids either systemically or topically (eg, etretinate, isotretinoin,
      tazarotene, tretinoin, adapalene)

      - Alpha hydroxy acids (eg, glycolic acid, lactic acid) to > 5% of the skin

      - 5 fluorouracil or imiquimod and/or

      - Itraconazole

   - Has received treatment with systemic chemotherapy or agents known to be inhibitors of
   HH signaling, within 60 days to starting study medication

   - Currently receiving systemic medications that could affect BCC tumors (eg, oral
   retinoids) or might interact with remetinostat

   - Uncontrolled intercurrent illness including, but not limited to, ongoing or active
   infection, recurrent seizure history or psychiatric illness/social situations that
   would limit compliance with study requirements

   - Immunosuppression (eg, cancer, autoimmune disease) and/or receiving immunosuppressive
   drugs

   - Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)

   - History of congestive heart failure; cardiac arrhythmias; or other findings of
   ventricular dysfunction

   - History of current evidence of malabsorption or liver disease

   - Pregnancy or breast feeding

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Irene Bailey-Healy
408-892-7261
Not Recruiting