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Topical Itraconazole in Treating Patients With Basal Cell Cancer

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ClinicalTrials.gov Identifier: NCT02735356
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University

Brief Summary:
This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.

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

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).

SECONDARY OBJECTIVES:

I. To determine if topical itraconazole gel will decrease BCC size.

OUTLINE:

Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.

After completion of study treatment, patients are followed up for up to 14 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
Actual Study Start Date : May 5, 2016
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (itraconazole and placebo)
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Drug: Itraconazole
Applied topically
Other Names:
  • Lozanoc
  • Oriconazole
  • R 51,211
  • Sporanox

Other: Placebo
Applied topically
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy




Primary Outcome Measures :
  1. Percentage change of GLi levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]
    will be assessed as relative GLi1 mRNA expression


Secondary Outcome Measures :
  1. Change in BCC tumor size [ Time Frame: At baseline, 1, 4, and 12 weeks ]
    Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).



Information from the National Library of Medicine

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

Inclusion Criteria:

  • The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
  • The subject must be willing to apply the medications twice daily for 1 month
  • The subjects must have at least four BCCs in non-cosmetically sensitive sites
  • 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 to prevent exposing a fetus to potentially dangerous agent with unknown risk
  • For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • History of congestive heart failure or other findings of ventricular dysfunction
  • History of current evidence of malabsorption or liver disease
  • Current immunosuppression or taking immunosuppressive drugs
  • Taking oral itraconazole
  • Taking any medication known to affect hedgehog (HH) signaling pathway
  • The subject 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 (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication

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): NCT02735356


Locations
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United States, California
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Jean Yuh Tang
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anthony Oro Stanford Cancer Institute

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Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT02735356     History of Changes
Other Study ID Numbers: IRB-35672
NCI-2016-00452 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0030 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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