Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face

NCT00489086 | Completed Phase 2 Results

• 2 other identifiers: CDR0000551655R01CA109584
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.

Conditions

Neoplastic Syndrome

Keywords

nevoid basal cell carcinoma syndrome; basal cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.

  36 months

Secondary Outcomes (4)

• Time to Lesion Clearance

  36 months

• Time to Progression

  36 months

• Estimated Duration of Complete Response

  36 months

• Overall Response at Treated Lesions

  36 months

Study Arms (1)

Tazarotene Cream

OTHER

Open label

Drug: tazarotene

Interventions

tazarotene DRUG

Tazarotene is a member of the acetylenic class of retinoids.

Also known as: tazorac

Tazarotene Cream

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects must have at least one basal cell carcinoma ≥ 3mm in diameter (target lesion) on any area of the skin except the face, chest, and back (and not impinging on vital sites) diagnosed clinically by a Study Investigator at the baseline visit.
• Study subjects must meet diagnostic criteria for basal cell nevus syndrome including major criterion #1 plus one additional major criterion or two of the minor criteria outlined in Table I. A first degree relative would satisfy BCNS diagnostic criteria with any two major criteria or any single major plus two minor criteria.
• Table I. BCNS Diagnostic Criteria
• Major criteria
• More than 2 BCCs or one under the age of 20 years
• Odontogenic keratocysts of the jaw proven by histology
• Three or more palmar and/or plantar pits
• Bilamellar calcification of the falx cerebri (if less than 20 years old)
• Fused, bifid, or markedly splayed ribs.
• First degree relative with basal cell nevus syndrome (BCNS)
• PTCH1 gene mutation in normal tissue\*
• Minor criteria
• Macrocephaly determined after adjustment for height
• Congenital malformations: cleft lip or palate, frontal bossing, "coarse face."
• Skeletal abnormalities: Sprengel deformity, marked pectus deformity

You may not qualify if:

• The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study.
• The subject has a history of hypersensitivity to any of the ingredients in the study medication formulations.
• The subject is unable to return for follow-up tests.
• The subject has uncontrolled systemic disease, including known HIV positive patients.
• The subject has a history of other skin conditions or significant illness that would interfere with evaluation of the study medication.
• Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study.
• The subject has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, or CLL Stage 0.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Tang JY, Chiou AS, Mackay-Wiggan JM, Aszterbaum M, Chanana AM, Lee W, Lindgren JA, Raphael MA, Thompson BJ, Bickers DR, Epstein EH Jr. Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome. Cancer Prev Res (Phila). 2014 Mar;7(3):292-9. doi: 10.1158/1940-6207.CAPR-13-0305. Epub 2014 Jan 17.

  PMID: 24441673 RESULT

MeSH Terms

Conditions

Neoplasms; Basal Cell Nevus Syndrome; Carcinoma, Basal Cell

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Ervin H Epstein Jr., MD
• Organization: Children's Hospital of Oakland Research Institute, Oakland

eepstein@chori.org

510-450-5688

Study Officials

• Ervin Epstein, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

• David R. Bickers, MD

  Herbert Irving Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: July 1, 2004
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 29, 2020
• Results First Posted: February 11, 2016

Record last verified: 2020-10

Locations

US (2)