Topical Itraconazole in Treating Patients With Basal Cell Cancer

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

Tracking Information

• First Submitted Date: March 31, 2016
• First Posted Date: April 12, 2016
• Last Update Posted Date: April 11, 2019
• Actual Study Start Date: May 5, 2016
• Actual Primary Completion Date: September 19, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Itraconazole in Treating Patients With Basal Cell Cancer
• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Skin Basal Cell Carcinoma

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2017): 9
• Original Estimated Enrollment (submitted: April 11, 2016): 5
• Actual Study Completion Date: October 10, 2017
• Actual Primary Completion Date: September 19, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02735356
• 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 )
• 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

• Plan to Share IPD: Yes

• Current Responsible Party: Jean Yuh Tang, Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Jean Yuh Tang
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Anthony Oro; Stanford Cancer Institute

• PRS Account: Stanford University
• Verification Date: April 2019