Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 75	NCI	CHORI-2007-016 UCSF-05862, R01-CA-109584, NCT00489086, 05862

Objectives

1. Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS).
2. Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs.

Entry Criteria

Disease Characteristics:

• Diagnosis of ≥ 1 basal cell carcinoma (BCC) ≥ 3 mm (not impinging on vital sites) on the face



• Meets 1 of the following criteria for diagnosis of basal cell nevus syndrome (BCNS)
  • Has major criterion # 1 (first in the list of major criteria) AND 1 additional major criterion OR 2 minor criteria
  • Has a first degree relative with BCNS AND any 2 major criteria or any single major plus 2 minor criteria



• Major criteria include:
  • More than 2 BCCs total OR 1 BCC before 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 BCNS
  • PTCH1 gene mutation in normal tissue



• Minor criteria include:
  • Macrocephaly determined after adjustment for height
  • Congenital malformations (i.e., cleft lip or palate, frontal bossing, “coarse face”, moderate or severe hypertelorism)
  • Skeletal abnormalities (i.e., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits)
  • Radiological abnormalities (i.e., bridging of the sella turcica or vertebral anomalies, such as hemivertebrae, fusion or elongation of the vertebral bodies, modeling defects of the hands and feet, or flame shaped lucencies of the hands or feet)
  • Ovarian fibroma
  • Medulloblastoma

Prior/Concurrent Therapy:

• No prior topical or systemic therapies that would interfere with the evaluation of the study medication
• At least 30 days since prior systemic investigational medication or topical investigational medication to the face
• At least 6 months since prior systemic or topical retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, or adapalene) or glucocorticoids (other than ≤ 1% hydrocortisone applied no more than 6 times/month) to the face
• At least 6 months since prior systemic or topical alpha hydroxy acids (e.g., glycolic acid or lactic acid) to the face
• At least 6 months since prior topical chemotherapeutic agents (e.g., fluorouracil, retinoids, or imiquimod) to the face as chemoprevention prophylaxis
• At least 1 year since prior systemic chemotherapy
• No other concurrent topical medications to the face, including prescription and over-the-counter preparations (e.g., topical preparations containing corticosteroids [other than ≤ 1% hydrocortisone applied no more than 6 times/month]) or vitamin A derivatives
• No concurrent enrollment in another clinical investigational drug or device trial that involves systemic administration of the drug or use of the drug/device on the face
• No other concurrent systemic retinoids, chemotherapeutic agents, or local treatment to the face (e.g., laser resurfacing, imiquimod, fluorouracil, alpha hydroxy acids, irradiation, or topical or systemic photodynamic therapy [except as localized treatment of specific tumors])
• Concurrent moisturizers and emollients allowed

Patient Characteristics:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing to apply sunscreen (SPF ≥ 15) at least once daily on all exposed skin sites
• No history of hypersensitivity to any of the ingredients in the study medication formulations
• No uncontrolled systemic disease
• No known HIV positivity
• No history of other skin conditions or significant illness that would interfere with evaluation of the study medication
• No condition or situation that, in the investigator’s opinion, may put the patient at significant risk, could confound the study results, or could significantly interfere with the patient’s participation in the study

Expected Enrollment

Outcomes

Complete response rate

Time to lesion clearance
Time to progression
Estimated duration of complete response
Overall response at treated lesions

Outline

This is an open-label, multicenter study.

Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Children's Hospital and Research Center Oakland

Ervin Epstein, MD, Principal investigator		Ph: 510-450-7639 Email: eepstein@chori.org
David Bickers, MD, Principal investigator		Ph: 212-305-5565 Email: drb25@columbia.edu

U.S.A.
California
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		David Bickers, MD	Ph:  212-305-5565
			Email: drb25@columbia.edu

Registry Information
Official Title		A Phase II Single Arm Open-Label Clinical Trial of Chemotherapy of BCC's with Tazarotene 0.1% in Subjects with Basal Cell Nevus Syndrome
Trial Start Date		2004-07-01
Trial Completion Date		2011-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00489086
Date Submitted to PDQ		2007-05-14
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA82103, CA109584

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