- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120677
Topical Itraconazole in the Treatment of Basal Cell Carcinoma
A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins School of Medicine, Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Downregulation in glucagon-like immunoreactivity (GLI) expression
Time Frame: Day 8
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We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
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Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence, timing, and severity of treatment adverse events
Time Frame: 45 days
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Data on adverse events will be collected and reported by treatment cohort and overall.
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45 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nikki Tang, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Basal Cell
- Carcinoma
- Carcinoma, Basal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
Other Study ID Numbers
- NA_00077461
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of MiamiCompletedNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
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Berg, LLCCompletedSuperficial Basal Cell CarcinomaUnited States
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PeplinCompletedSuperficial Basal Cell CarcinomaAustralia
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Halcygen Pharmaceuticals LimitedCompletedOnychomycosisUnited States
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H. Lundbeck A/SCompletedCytochrome P450 InteractionUnited Kingdom, United States
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Sara BotrosCompleted
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Pulmatrix Inc.Completed
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Stiefel, a GSK CompanyGlaxoSmithKlineCompletedOnychomycosisUnited States, South Africa, Canada, Dominican Republic, Ecuador, Honduras, Panama
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Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedNon-small Cell Lung Cancer MetastaticUnited States