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

NCT00783965 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR00006182405R01CA109584-05U19CA081888
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Skin Carcinoma

Keywords

nevoid basal cell carcinoma syndrome; basal cell carcinoma of the skin

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter

  Baseline and 36 months

• Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0

  Baseline and 36 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.

Drug: tazarotene; Other: placebo

Arm II

EXPERIMENTAL

Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.

Drug: tazarotene; Other: placebo

Interventions

tazarotene DRUG

Applied to the skin

Also known as: tazorac

Arm I; Arm II

placebo OTHER

Applied to the skin

Also known as: vehicle

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• More than 2 BCCs or one 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: cleft lip or palate, frontal bossing, "coarse face."
• Skeletal abnormalities: Sprengel deformity, marked pectus deformity

You may not qualify if:

• The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study.
• The subject has a history of hypersensitivity to any of the ingredients in the study medication formulations.
• The subject is unable to return for follow-up tests.
• The subject has uncontrolled systemic disease, including known HIV positive patients.
• The subject has a history of other skin conditions or significant illness that would interfere with evaluation of the study medication.
• 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.
• 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.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Children's Hospital Oakland Research Institute

Oakland, California, 94609-1693, United States

Location

Children's Hospital Oakland Research Institiute

Oakland, California, 94609, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Basal Cell Nevus Syndrome; Carcinoma, Basal Cell

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Limitations and Caveats

Non-compliance and large drop-out rates leading to small numbers of data analyzed.

Results Point of Contact

• Title: Raj Prasad
• Organization: ChildrensHRCOakland

rprasad@chori.org

510-450-7602

Study Officials

• Ervin Epstein, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

• David R. Bickers, MD

  Herbert Irving Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: July 1, 2004
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2014
• Last Updated: February 11, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-01

Locations

US (3)