Know Cancer

or
forgot password

A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome


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

Thank you

Trial Information

A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome


OBJECTIVES:

Primary

- To expand and refine chemopreventive strategies in individuals with basal cell nevus
syndrome (BCNS) on the chest and back, who are at high risk for the development of
basal cell carcinomas (BCCs).

- To determine whether tazarotene 0.1% cream applied to the chest for two years will
reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number
expected, based on changes in BCC numbers observed during months 0-12.

Secondary

- To compare the difference in total BCC burden (measured as the total lesion surface
area) between chest and back over various time points and aggregated intervals of
interest.

- To determine whether there are any detectable wash-in or wash-out periods for the
tazarotene effects.

- Explore the use of a random effects model for longitudinal analysis of total lesions
over time.

OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

- Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on
months 13-36 once daily to the chest in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on
months 13-36 once daily to the chest in the absence of disease progression or
unacceptable toxicity.

Treated chest and untreated back is evaluated at 3 month intervals for 36 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or clinically diagnosed with at least 3 basal cell carcinomas (BCCs) ≥
9 mm² in diameter on both the chest and back within the past year

- Meets above criterion as well as one additional major criterion or two minor
criteria:

- Major criteria:

- More than 2 histologically confirmed BCCs (1 for patients 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 (e.g., cleft lip or palate, frontal bossing,
"coarse face", moderate or severe hypertelorism)

- Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity,
or marked syndactyly of the digits)

- Radiological abnormalities (e.g., bridging of the sella turcica, 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

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of invasive cancer within the past five years except nonmelanoma skin
cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia

- No history of hypersensitivity to any of the ingredients in the study medication
formulations

- No uncontrolled systemic disease, including known HIV positivity

- No history of other skin conditions or significant illness that would interfere with
evaluation of the study medication

- No history of any condition or situation that, in the opinion of the Investigator,
might interfere with the patient's ability to comply with the protocol or pose
additional or unacceptable risk to the patient

- Able to return for follow-up tests

PRIOR CONCURRENT THERAPY:

- No prior topical or systemic therapies that might interfere with the evaluation of
the study medication including the following:

- Glucocorticoids (other than ≤ 1% triamcinolone)

- Retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
within the past six months

- Alpha-hydroxy acids (e.g., glycolic acid, lactic acid)

- At least 6 months since prior 5-fluorouracil or imiquimod (except as treatment
to discrete basal cell carcinomas)

- At least 30 days since prior systemic investigational medication or any topical
investigational medication to the chest or back

- At least 1 year since prior treatment with systemic chemotherapy

- No concurrent non-study topical medications to the skin of the chest and back,
including prescription and over the counter preparations (e.g., corticosteroids
[other than ≤ 0.1% triamcinolone applied no more than 6 times/month] or vitamin A)

- Concurrent moisturizers and emollients are allowed

- Patients must use sunscreen (SPF ≥ 15) at least once daily on all exposed skin sites
during study treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Reduction in the observed numbers of basal cell carcinomas ≥ 9 mm² in diameter

Safety Issue:

No

Principal Investigator

Ervin Epstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital & Research Center Oakland

Authority:

United States: Federal Government

Study ID:

CDR0000618240

NCT ID:

NCT00783965

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

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Children's Hospital Oakland Research InstituteOakland, California  94609-1693