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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00489086
First received: June 20, 2007
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 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.


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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to lesion clearance [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Estimated duration of complete response [ Designated as safety issue: No ]
  • Overall response at treated lesions [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: July 2004
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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
  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: NCT00489086

Locations
United States, California
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
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: NCT00489086     History of Changes
Obsolete Identifiers: NCT00500643
Other Study ID Numbers: CDR0000551655, R01CA109584, P30CA082103, CHORI-2007-016, UCSF-05862
Study First Received: June 20, 2007
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 November 25, 2014