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| Sponsor: | Children's Hospital & Research Center Oakland |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00783965 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplastic Syndrome Non-Melanomatous Skin Cancer |
Drug: tazarotene Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome |
| Estimated Enrollment: | 42 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Applied to the skin
Other: placebo
Applied to the skin
|
|
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
Applied to the skin
Other: placebo
Applied to the skin
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.
Treated chest and untreated back is evaluated at 3 month intervals for 36 months.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets above criterion as well as one additional major criterion or two minor criteria:
Major criteria:
Minor criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior topical or systemic therapies that might interfere with the evaluation of the study medication including the following:
Contacts and Locations| United States, California | |
| Children's Hospital Oakland Research Institute | Recruiting |
| Oakland, California, United States, 94609-1693 | |
| Contact: Ervin Epstein, MD 510-450-7639 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| Principal Investigator: | Ervin Epstein, MD | Children's Hospital & Research Center Oakland |
| Principal Investigator: | David R. Bickers, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Responsible Party: | Children's Hospital Oakland Research Institute ( Ervin Epstein, Jr ) |
| Study ID Numbers: | CDR0000618240, CHORI-2007-022, CHORI-H473-26042 |
| Study First Received: | October 31, 2008 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00783965 History of Changes |
| Health Authority: | Unspecified |
|
nevoid basal cell carcinoma syndrome basal cell carcinoma of the skin |
|
Jaw Diseases Jaw Cysts Bone Diseases Keratolytic Agents Odontogenic Cysts Basal Cell Nevus Syndrome Pathologic Processes Neoplasms by Site Musculoskeletal Diseases Therapeutic Uses Syndrome Bone Cysts Bone Diseases, Developmental Abnormalities, Multiple Neoplasms, Basal Cell |
Congenital Abnormalities Dermatologic Agents Tazarotene Neoplasms by Histologic Type Disease Skin Diseases Carcinoma, Basal Cell Cysts Skin Neoplasms Pharmacologic Actions Carcinoma Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Stomatognathic Diseases |