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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00783965
First received: October 31, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.


Condition Intervention Phase
Neoplastic Syndrome
Non-melanomatous Skin Cancer
Drug: tazarotene
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Reduction in the observed numbers of basal cell carcinomas ≥ 9 mm² in diameter [ Designated as safety issue: No ]
  • Parameters of safety [ Designated as safety issue: Yes ]
  • Adverse events according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: July 2004
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
Drug: tazarotene
Applied to the skin
Other: placebo
Applied to the skin
Experimental: Arm II
Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
Drug: tazarotene
Applied to the skin
Other: placebo
Applied to the skin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783965

Locations
United States, California
Children's Hospital Oakland Research Institute
Oakland, California, United States, 94609-1693
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ervin Epstein, MD Children's Hospital & Research Center Oakland
Principal Investigator: David R. Bickers, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ervin Epstein, Jr, Children's Hospital Oakland Research Institute
ClinicalTrials.gov Identifier: NCT00783965     History of Changes
Other Study ID Numbers: CDR0000618240, CHORI-2007-022, CHORI-H473-26042
Study First Received: October 31, 2008
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital & Research Center Oakland:
nevoid basal cell carcinoma syndrome
basal cell carcinoma of the skin

Additional relevant MeSH terms:
Basal Cell Nevus Syndrome
Skin Neoplasms
Syndrome
Abnormalities, Multiple
Bone Cysts
Bone Diseases
Bone Diseases, Developmental
Carcinoma
Carcinoma, Basal Cell
Congenital Abnormalities
Cysts
Disease
Genetic Diseases, Inborn
Jaw Cysts
Jaw Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Odontogenic Cysts
Pathologic Processes
Skin Diseases
Stomatognathic Diseases
Tazarotene
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014