Clincosm LogoSign in Get a demo

Topical Itraconazole in Treating Patients With Basal Cell Cancer

Sponsor
Jean Yuh Tang (Other)
Overall Status
Completed
CT.gov ID
NCT02735356
Collaborator
National Cancer Institute (NCI) (NIH)
9
Enrollment
1
Location
1
Arm
17.2
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
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 :
Sep 19, 2017
Actual Study Completion Date :
Oct 10, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change of GLi levels in treated vs untreated tumors [Up to 1 month]

      will be assessed as relative GLi1 mRNA expression

    Secondary Outcome Measures

    1. Change in BCC tumor size [At baseline, 1, 4, and 12 weeks]

      Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto California United States 94304

    Sponsors and Collaborators

    • Jean Yuh Tang
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Anthony Oro, Stanford Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02735356
    Other Study ID Numbers:
    • IRB-35672
    • NCI-2016-00452
    • SKIN0030
    • P30CA124435
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    Apr 11, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Basal Cell
    Itraconazole

    Study Results

    No Results Posted as of Apr 11, 2019