Education and Training
Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer
This phase 2 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.
Intervention(s):
- drug: Remetinostat
Eligibility
Inclusion Criteria:
- Must have at least one BCC lesion > 1 cm (BCC > 5 mm) in non-cosmetically sensitive
site(s)
- Must be willing to apply the topical remetinostat 3 times daily for 6 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
- Moderate to severe immunosuppression due to disease or medication
- 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
650-721-7149
Not Recruiting