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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

Phase 2
18 Years
75 Years
Not Enrolling
Neoplastic Syndrome, Non-melanomatous Skin Cancer

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Trial Information

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


- 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).

- Expand and refine chemopreventive strategies in patients with BCNS who are at high risk
for the development of BCCs.

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.

Inclusion Criteria


- 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


- 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

- 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


- 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

- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Safety Issue:


Principal Investigator

Ervin Epstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital & Research Center Oakland


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Neoplastic Syndrome
  • Non-melanomatous Skin Cancer
  • nevoid basal cell carcinoma syndrome
  • basal cell carcinoma of the skin
  • Basal Cell Nevus Syndrome
  • Neoplasms
  • Skin Neoplasms
  • Carcinoma, Basal Cell



Children's Hospital and Research Center Oakland Oakland, California  94609
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032