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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00550589
Other study ID # AMC-046
Secondary ID U01CA121947CDR00
Status Completed
Phase Phase 2
First received October 26, 2007
Last updated November 17, 2015
Start date September 2007
Est. completion date February 2010

Study information

Verified date November 2015
Source AIDS Malignancy Consortium
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming cancer.

PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of the skin near the anus.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston University Cancer Research Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States UCLA Clinical AIDS Research and Education (CARE) Center Los Angeles California
United States Laser Surgery Care New York New York
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Benaroya Research Institute at Virginia Mason Medical Center Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
AIDS Malignancy Consortium National Cancer Institute (NCI), The EMMES Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stier EA, Goldstone SE, Einstein MH, Jay N, Berry JM, Wilkin T, Lee JY, Darragh TM, Da Costa M, Panther L, Aboulafia D, Palefsky JM. Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) 6 weeks after treatment discontinuation
Primary Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0 Number of study patients who had a serious adverse event Every 2 weeks on study, 6 weeks after treatment discontinuation
Secondary Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue Baseline
Secondary Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA Number of patients who cleared HPV among those who had a complete or partial response 6 weeks after treatment discontinuation
Secondary Identification of HPV-DNA Types Present in the Anus Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline Baseline
Secondary Identification of Abnormally Methylated Genes in Perianal Dysplasia Identification of abnormally methylated genes in perianal dysplasia Baseline, after cycle 1, and 6 weeks after treatment discontinuation
Secondary Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin Baseline, after cycle 1, and 6 weeks after treatment discontinuation
Secondary Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis Baseline, after cycle 1, and 6 weeks after treatment discontinuation
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