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Neoplastic SyndromePhase 2NCT00489086

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

A Phase 2 study testing tazarotene in people with Neoplastic Syndrome, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplastic Syndrome
What is being tested?
tazarotene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
Jul 2004to Jun 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

  1. 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:
  2. 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.
  3. 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.
  4. 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Children's Hospital and Research Center Oakland

    Oakland, California, 94609

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
tazarotene
Keywords
nevoid basal cell carcinoma syndrome, basal cell carcinoma of the skin
Medical subject headings
Neoplasms, Basal Cell Nevus Syndrome, Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tazaroteneDrug

    Also called tazorac

    Tazarotene is a member of the acetylenic class of retinoids.

Study groups in NCT00489086
Study groupRoleWhat they receive
Tazarotene CreamOtherOpen label
Receives: Drug: tazarotene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate

    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.

    Measured: 36 months

Secondary outcomes (4)

  1. Time to Lesion Clearance

    Measured: 36 months

  2. Time to Progression

    Measured: 36 months

  3. Estimated Duration of Complete Response

    Measured: 36 months

  4. Overall Response at Treated Lesions

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2007 (estimated)
  2. Study startJul 2004
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00489086
Sponsor's protocol ID
CDR0000551655
Other IDs
R01CA109584
Status last verified
Oct 2020
First submitted
20 Jun 2007
Last updated
29 Oct 2020
Data monitoring committee
No

Publications

  • Tang JY, Chiou AS, Mackay-Wiggan JM, Aszterbaum M, Chanana AM, Lee W, Lindgren JA, Raphael MA, Thompson BJ, Bickers DR, Epstein EH Jr. Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome. Cancer Prev Res (Phila). 2014 Mar;7(3):292-9. doi: 10.1158/1940-6207.CAPR-13-0305. Epub 2014 Jan 17.

    PubMed 24441673

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tazarotene in people with Neoplastic Syndrome, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00489086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.

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