Topical Itraconazole in Treating Patients With Basal Cell Cancer

NCT02735356 | Completed Early Phase 1 DMC FDA Drug

• 4 other identifiers: IRB-35672NCI-2016-00452SKIN0030P30CA124435
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage change of GLi levels in treated vs untreated tumors

  will be assessed as relative GLi1 mRNA expression

  Up to 1 month

Secondary Outcomes (1)

• Change in BCC tumor size

  At baseline, 1, 4, and 12 weeks

Study Arms (1)

Treatment (itraconazole and placebo)

EXPERIMENTAL

Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.

Drug: Itraconazole; Other: Placebo

Interventions

Itraconazole DRUG

Applied topically

Also known as: Lozanoc, Oriconazole, R 51,211, Sporanox

Treatment (itraconazole and placebo)

Placebo OTHER

Applied topically

Also known as: placebo therapy, PLCB, sham therapy

Treatment (itraconazole and placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jean Yuh Tang: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Anthony Oro

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: May 5, 2016
• Primary Completion: September 19, 2017
• Study Completion: October 10, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)