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Topical Itraconazole in the Treatment of Basal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02120677
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: Itraconazole Early Phase 1

Detailed Description:

Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although rarely metastatic, it can be locally destructive causing disfigurement and pain. Current therapies include surgical removal, local destruction, radiotherapy and others.

Advances in understanding the molecular basis behind BCCs indicate that mutations in the hedgehog signaling pathway can lead to the development of many sporadically occurring basal cell carcinomas (BCCs). An oral drug that targets the hedgehog signaling pathway has been shown to be effective in treating patients with metastatic and inoperable BCCs. There is evidence that itraconazole, a commonly prescribed antifungal medication may also affect this pathway. It is not known whether itraconazole ointment applied topically can affect the growth of BCCs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Actual Study Start Date : May 2014
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itraconazole ointment
Patients with histologically proven BCC will be eligible for study enrollment. 50% itraconazole compounded in petrolatum jelly will be applied under occlusion for up to 3 to 7 days.
Drug: Itraconazole
Itraconazole comes in the form of capsules and liquid (oral solution). It is FDA approved for treatment of systemic Blastomycosis, Histoplasmosis and Aspergillosis in immunocompromised and non-immunocompromised patients at doses ranging from 200mg to 400mg daily. The current FDA approved dosage recommendation for treating toenail onychomycosis (nail fungus) is 200mg PO per day for 3 months. Test materials in this study will be prepared as an ointment (compounded in petrolatum jelly).
Other Name: Sporanox




Primary Outcome Measures :
  1. Downregulation in glucagon-like immunoreactivity (GLI) expression [ Time Frame: Day 8 ]
    We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.


Secondary Outcome Measures :
  1. Incidence, timing, and severity of treatment adverse events [ Time Frame: 45 days ]
    Data on adverse events will be collected and reported by treatment cohort and overall.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be over the age of 18 years
  • Male
  • Women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
  • Have a biopsy confirmed BCC that measures at least 6mm in size at the time of the initial evaluation (visit #1);
  • Participant must be willing and comply with the requirements of the protocol;
  • Participant must have the ability to understand and communicate with the investigator;
  • Participant must provide informed consent.

Exclusion Criteria:

  • Subject with significant congestive heart failure (CHF) or history of CHF, chronic renal failure, hepatic failure, neuropathy
  • Subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous T-cell lymphoma, erythroderma;
  • Subjects on systemic medications known to affect the Hedgehog pathway (see Appendix I)
  • Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
  • Subjects with history of hypersensitivity to azoles
  • Subjects with Gorlin syndrome
  • Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
  • Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
  • Subjects with a history of keloids or excessive scarring;
  • Subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum
  • Women of child-bearing age/potential and/or able to conceive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120677


Locations
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United States, Maryland
Johns Hopkins School of Medicine, Department of Dermatology
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Nikki Tang, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02120677     History of Changes
Other Study ID Numbers: NA_00077461
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Johns Hopkins University:
skin cancer
basal cell carcinoma
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors