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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Prevention, Treatment Active 18 to 75 Other 2007-018 NCT00500643

Trial Description

Summary

This is a 36 month, multi-center, single arm, open label clinical study design. During the treatment period (month 0-18), the safety and efficacy of 0.1% tazarotene cream will be compared with that of the untreated months 18-36. Daily application of the study medication for 18 months will be for the treatment and prevention of basal cell carcinomas. Evaluations of the face and target lesion will be done at the study centers at 3 month intervals from months 0-36. Removal of BCCs will be done by Primary Skin Care Physicians (PSCPs) or at study centers.

Eligibility Criteria

Inclusion Criteria:

The following are requirements for entry into the study:

4.2.1 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.

4.2.2 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 Minor criteria

1. More than 2 BCCs or one under the age of 20 years 1. Macrocephaly determined after adjustment for height

2. Odontogenic keratocysts of the jaw proven by histology 2. Congenital malformations: cleft lip or palate, frontal bossing, “coarse face”, moderate or severe hypertelorism

3. Three or more palmar and/or plantar pits 3. Skeletal abnormalities: Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits

4. Bilamellar calcification of the falx cerebri (if less than 20 years old) 4. Radiological abnormalities: 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

5. Fused, bifid, or markedly splayed ribs. 5. Ovarian fibroma

6. First degree relative with basal cell nevus syndrome (BCNS) 6. Medulloblastoma

7. PTCH1 gene mutation in normal tissue*

*modification of criteria outlined by Kimonis et al, Am J Med Genetics 69:299-308, 1997

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

4.2.4 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.

4.2.5 The subject must sign and date all informed consent statements.

4.2.6 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. For example, topical preparations containing corticosteroids (other than

 1% hydrocortisone applied no more than 6 times per month) or vitamin A derivatives are not allowed. Moisturizers and emollients are allowable. Subjects will be encouraged to use sunscreen (SPF  15) at least once daily on all exposed skin sites.

4.2.7 The subject is willing to contact the study center after each PSCP visit to inform the center re the occurrence of the visit and re any treatment of skin tumors.

4.2.8 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.

Exclusion Criteria:

4.3.1 The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically these include the use of (i) glucocorticoids (other than  1% hydrocortisone on no more than 36 days during the six months prior to study entry), (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically to the chest or back during the six months prior to study entry (except for subjects concurrently enrolled in Trial 1- Chemoprevention Trial); (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) (iv) 5-fluorouracil or imiquimod (except as treatment to discrete BCCs) systemically or topically to the chest or back during the six months prior to study entry. (v) any systemic investigational medication or any topical investigational medication to the chest or back within 30 days prior to randomization or is scheduled to receive a systemic investigational medication or a topical investigational medication, other than tazarotene, to the chest or back during the course of the study. (vi) treatment with systemic chemotherapy within one year prior to starting study medication.

4.3.2 The subject has a history of hypersensitivity to any of the ingredients in the study medication formulations.

4.3.3 The subject is unable to return for follow-up tests.

4.3.4 The subject has uncontrolled systemic disease, including known HIV positive patients.

4.3.5 The subject has a history of other skin conditions or significant illness that would interfere with evaluation of the study medication.

4.3.6 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.

4.3.7 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 Contact Information

Trial Lead Organizations/Sponsors

Children's Hospital and Research Center Oakland

Ervin H Epstein, MD

Principal Investigator

David Bickers, MD

Principal Investigator

Ervin H Epstein, MD
		Email: eepstein@chori.org

Jean Y Tang, MD PhD
		Email: tangy@stanford.edu

U.S.A.
California
	Newport Beach
	Michelle Aszterbaum
		Michelle Aszterbaum, MD
	Oakland
	Children's Hospital and Research Center Oakland
		Jean Y Tang, MD PhD	Sub-Investigator
		Ervin H Epstein, MD	Principal Investigator
New York
	Columbia
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		David Bickers, MD	Ph: 212-305-5565
		David Bickers, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00500643
Information obtained from ClinicalTrials.gov on February 22, 2008