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Topical Itraconazole in Treating Patients With Basal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE May 5, 2016
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Percentage change of GLi levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]
will be assessed as relative GLi1 mRNA expression
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Itraconazole in Treating Patients With Basal Cell Cancer
Official Title  ICMJE A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Basal Cell Carcinoma
Intervention  ICMJE
  • Drug: Itraconazole
    Applied topically
    Other Names:
    • Lozanoc
    • Oriconazole
    • R 51,211
    • Sporanox
  • Other: Placebo
    Applied topically
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
Study Arms  ICMJE Experimental: Treatment (itraconazole and placebo)
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Interventions:
  • Drug: Itraconazole
  • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2016)
5
Actual Study Completion Date  ICMJE October 10, 2017
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735356
Other Study ID Numbers  ICMJE IRB-35672
NCI-2016-00452 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0030 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Jean Yuh Tang, Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jean Yuh Tang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anthony Oro Stanford Cancer Institute
PRS Account Stanford University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP