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Sponsored by: |
National Naval Medical Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079300 |
RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.
Condition | Intervention | Phase |
Non-Melanomatous Skin Cancer |
Drug: imiquimod Procedure: conventional surgery |
Phase I |
MedlinePlus related topics: | Cancer Skin Cancer |
Drug Information available for: | S 26308 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study.
Patients undergo fine needle aspiration and punch biopsies of the target lesion. Patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy.
All patients undergo excision of the target tumor within 18-30 hours after the last topical treatment.
Patients are followed at 7-14 days.
PROJECTED ACCRUAL: A total of 48 patients (8 per treatment arm and 4 per placebo arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed basal cell skin cancer
At least 1 lesion at least 7 mm in diameter that meets the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |||||
NIH - Warren Grant Magnuson Clinical Center | |||||
Bethesda, Maryland, United States, 20892-1182 |
National Naval Medical Center |
Principal Investigator: | Francesco M. Marincola, MD | NIH - Warren Grant Magnuson Clinical Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000355151, NCI-02-CC-0289, 3M-1454-IMIQ |
First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00079300 |
Health Authority: | United States: Federal Government |
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