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Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Primary Purpose

Non-melanomatous Skin Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed basal cell carcinoma (BCC) At least 5 prior BCCs AND At least 4 BCCs within the past year Meets diagnostic criteria for basal cell nevus syndrome (BCNS) Any 1 of the following: More than 2 BCCs or 1 before age 20 Histologically confirmed odontogenic keratocysts of the jaw 3 or more palmar and/or plantar pits Bilamellar calcification of the falx cerebri (if less than 20 years of age) Fused, bifid, or markedly splayed ribs First degree relative with BCNS PTC gene mutation in normal tissue OR Any 2 of the following: Macrocephaly determined after adjustment for height Congenital malformations (e.g., cleft lip or palate, frontal bossing, "coarse face", or moderate or severe hypertelorism) Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits) Radiological abnormalities (e.g., bridging of the sella turcica, vertebral anomalies, modeling defects of the hands and feet, or flame-shaped lucencies of the hands or feet) Ovarian fibroma Medulloblastoma PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 125,000/mm^3 Hemoglobin greater than 12.0 g/dL (women) Hemoglobin greater than 13.0 g/dL (men) No significant coagulation defect Hepatic: Bilirubin normal ALT/AST no greater than 1.5 times upper limit of normal (ULN) No chronic or acute hepatic disorder Renal: Creatinine no greater than 1.5 times ULN BUN normal Electrolytes within normal No chronic or acute renal disorder Cardiovascular: No congestive heart failure Gastrointestinal: No active gastrointestinal disease No inflammatory bowel disease No chronic or acute pancreatic disorder No history of gastrointestinal ulceration allowed except with permission of primary care physician No esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days Stool hematest normal Other: No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer, stage I cervical cancer, stage 0 chronic lymphoblastic leukemia, or medulloblastoma No hypersensitivity to COX-2 inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides No other condition that would preclude study involvement Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior topical agents as chemoprevention At least 1 year since other prior chemotherapy Endocrine therapy: At least 1 month since prior oral or IV corticosteroids At least 6 months since prior inhaled corticosteroid use for longer than 4 weeks At least 2 weeks since prior topical glucocorticoids No concurrent topical glucocorticoids Concurrent oral and IV corticosteroid use of less than 2 weeks within 6 months allowed Concurrent inhaled corticosteroid use of less than 4 weeks within 6 months allowed Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior topical retinoids or alpha-hydroxy acids (e.g., glycolic acid or lactic acid) At least 2 weeks since prior topical medications At least 30 days since prior investigational agents At least 2 months since prior NSAIDs given more than 3 times/week At least 2 months since prior aspirin dose of more than 100 mg/day given more than 3 times/week At least 6 months since prior oral retinoids No concurrent chronic NSAIDs (more than 3 times per week for at least 2 weeks) No concurrent aspirin dose of more than 100 mg/day No concurrent topical medications No concurrent fluconazole No concurrent lithium No concurrent retinoids (including topical administration) or alpha-hydroxy acids No other concurrent investigational agents

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Outcomes

Primary Outcome Measures

Prevention of the development of basal cell carcinoma

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
June 25, 2013
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023621
Brief Title
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Official Title
A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma. PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.
Detailed Description
OBJECTIVES: Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms. Arm I: Patients receive oral celecoxib twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in the absence of unacceptable toxicity. Patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanomatous Skin Cancer
Keywords
basal cell carcinoma of the skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Primary Outcome Measure Information:
Title
Prevention of the development of basal cell carcinoma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed basal cell carcinoma (BCC) At least 5 prior BCCs AND At least 4 BCCs within the past year Meets diagnostic criteria for basal cell nevus syndrome (BCNS) Any 1 of the following: More than 2 BCCs or 1 before age 20 Histologically confirmed odontogenic keratocysts of the jaw 3 or more palmar and/or plantar pits Bilamellar calcification of the falx cerebri (if less than 20 years of age) Fused, bifid, or markedly splayed ribs First degree relative with BCNS PTC gene mutation in normal tissue OR Any 2 of the following: Macrocephaly determined after adjustment for height Congenital malformations (e.g., cleft lip or palate, frontal bossing, "coarse face", or moderate or severe hypertelorism) Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits) Radiological abnormalities (e.g., bridging of the sella turcica, vertebral anomalies, modeling defects of the hands and feet, or flame-shaped lucencies of the hands or feet) Ovarian fibroma Medulloblastoma PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 125,000/mm^3 Hemoglobin greater than 12.0 g/dL (women) Hemoglobin greater than 13.0 g/dL (men) No significant coagulation defect Hepatic: Bilirubin normal ALT/AST no greater than 1.5 times upper limit of normal (ULN) No chronic or acute hepatic disorder Renal: Creatinine no greater than 1.5 times ULN BUN normal Electrolytes within normal No chronic or acute renal disorder Cardiovascular: No congestive heart failure Gastrointestinal: No active gastrointestinal disease No inflammatory bowel disease No chronic or acute pancreatic disorder No history of gastrointestinal ulceration allowed except with permission of primary care physician No esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days Stool hematest normal Other: No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer, stage I cervical cancer, stage 0 chronic lymphoblastic leukemia, or medulloblastoma No hypersensitivity to COX-2 inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides No other condition that would preclude study involvement Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior topical agents as chemoprevention At least 1 year since other prior chemotherapy Endocrine therapy: At least 1 month since prior oral or IV corticosteroids At least 6 months since prior inhaled corticosteroid use for longer than 4 weeks At least 2 weeks since prior topical glucocorticoids No concurrent topical glucocorticoids Concurrent oral and IV corticosteroid use of less than 2 weeks within 6 months allowed Concurrent inhaled corticosteroid use of less than 4 weeks within 6 months allowed Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior topical retinoids or alpha-hydroxy acids (e.g., glycolic acid or lactic acid) At least 2 weeks since prior topical medications At least 30 days since prior investigational agents At least 2 months since prior NSAIDs given more than 3 times/week At least 2 months since prior aspirin dose of more than 100 mg/day given more than 3 times/week At least 6 months since prior oral retinoids No concurrent chronic NSAIDs (more than 3 times per week for at least 2 weeks) No concurrent aspirin dose of more than 100 mg/day No concurrent topical medications No concurrent fluconazole No concurrent lithium No concurrent retinoids (including topical administration) or alpha-hydroxy acids No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ervin Epstein, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20956641
Citation
Tang JY, Wu A, Linos E, Parimi N, Lee W, Aszterbaum M, Asgari MM, Bickers DR, Epstein EH Jr. High prevalence of vitamin D deficiency in patients with basal cell nevus syndrome. Arch Dermatol. 2010 Oct;146(10):1105-10. doi: 10.1001/archdermatol.2010.247.
Results Reference
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Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

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