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Trial record 3 of 51 for:    tazarotene

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

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ClinicalTrials.gov Identifier: NCT00489086
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UCSF Benioff Children’s Hospital Oakland

Tracking Information
First Submitted Date  ICMJE June 20, 2007
First Posted Date  ICMJE June 21, 2007
Results First Submitted Date  ICMJE July 31, 2013
Results First Posted Date  ICMJE February 11, 2016
Last Update Posted Date February 11, 2016
Study Start Date  ICMJE July 2004
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Complete Response Rate [ Time Frame: 36 months ]
The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
Complete Response Rate
Change History Complete list of historical versions of study NCT00489086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Time to Lesion Clearance [ Time Frame: 36 months ]
  • Time to Progression [ Time Frame: 36 months ]
  • Estimated Duration of Complete Response [ Time Frame: 36 months ]
  • Overall Response at Treated Lesions [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
  • Time to Lesion Clearance
  • Time to Progression
  • Estimated Duration of Complete Response
  • Overall Response at Treated Lesions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplastic Syndrome
Intervention  ICMJE Drug: tazarotene
Tazarotene is a member of the acetylenic class of retinoids.
Other Name: tazorac
Study Arms  ICMJE Tazarotene Cream
Open label
Intervention: Drug: tazarotene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2016)
36
Original Enrollment  ICMJE
 (submitted: June 20, 2007)
26
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

List of Inclusion Criteria:

  1. Study subjects must have at least one basal cell carcinoma ≥ 3mm in diameter (target lesion) on any area of the skin except the face, chest, and back (and not impinging on vital sites) diagnosed clinically by a Study Investigator at the baseline visit.
  2. Study subjects must meet diagnostic criteria for basal cell nevus syndrome including major criterion #1 plus one additional major criterion or two of the minor criteria outlined in Table I. A first degree relative would satisfy BCNS diagnostic criteria with any two major criteria or any single major plus two minor criteria.

Table I. BCNS Diagnostic Criteria

Major criteria

  1. More than 2 BCCs or one under the age of 20 years
  2. Odontogenic keratocysts of the jaw proven by histology
  3. Three or more palmar and/or plantar pits
  4. Bilamellar calcification of the falx cerebri (if less than 20 years old)
  5. Fused, bifid, or markedly splayed ribs.
  6. First degree relative with basal cell nevus syndrome (BCNS)
  7. PTCH1 gene mutation in normal tissue*

Minor criteria

  1. Macrocephaly determined after adjustment for height
  2. Congenital malformations: cleft lip or palate, frontal bossing, "coarse face."
  3. Skeletal abnormalities: Sprengel deformity, marked pectus deformity
  4. Radiological abnormalities: bridging of the sella turcica, vertebral anomalies such as hemivertebrae, fusion or elongation of the vertebral bodies.
  5. Ovarian fibroma
  6. Medulloblastoma

3.The subject is from 18-75 years of age, inclusive.

4. If the subject is female and of child-bearing potential (women are considered not of childbearing potential if they are at least 2 years post-menopausal and/or surgically sterile), she:

i. has been using adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study, and ii. is not lactating, and iii. has documented one negative serum pregnancy test within 14 days prior to study entry.

5. The subject is willing to abstain from application of non-study topical medications to the skin of the face for the duration of the study, including prescription and over the counter preparations.

6. The subject is willing not to have targeted BCCs treated by their PSCP unless the BCCs are documented by Study Investigators, preferably on two separate visits, except when the PSCP believes that delay in treatment potentially might compromise the health of the subject.

List of Exclusion Criteria:

  1. The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study.
  2. The subject has a history of hypersensitivity to any of the ingredients in the study medication formulations.
  3. The subject is unable to return for follow-up tests.
  4. The subject has uncontrolled systemic disease, including known HIV positive patients.
  5. The subject has a history of other skin conditions or significant illness that would interfere with evaluation of the study medication.
  6. Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study.
  7. The subject has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, or CLL Stage 0.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00489086
Other Study ID Numbers  ICMJE CDR0000551655
R01CA109584 ( U.S. NIH Grant/Contract )
P30CA082103 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCSF Benioff Children’s Hospital Oakland
Study Sponsor  ICMJE UCSF Benioff Children’s Hospital Oakland
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ervin Epstein, MD UCSF Benioff Children’s Hospital Oakland
Principal Investigator: David R. Bickers, MD Herbert Irving Comprehensive Cancer Center
PRS Account UCSF Benioff Children’s Hospital Oakland
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP