Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Anus Neoplasms HIV Infections |
Procedure: Argon Plasma Coagulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Prospective, Open-label, Pilot Study of the Tolerability, Safety, and Efficacy of Argon Plasma Coagulation for the Treatment of Anal Intraepithelial Neoplasia Grade 2 or 3 in HIV-positive Men Having Sex With Men |
- High grade dysplasia (AIN 2/3) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
- Anal human papilloma virus (HPV) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
- Tolerability and safety of the treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | February 2007 |
| Study Completion Date: | July 2016 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Procedure: Argon Plasma Coagulation
Argon Plasma Coagulation (APC) is a non-contact electrosurgical technique delivering a high-frequency electrical current through ionized argon gas i.e. the argon plasma. This current produces a zone of coagulation, desiccation, and devitalisation 2-3 mm deep. Patients will be offered up to 3 treatments if recurrence occur after the first two.
|
Detailed Description:
HIV infected men having sex with men (MSM) are at increased risk of developing anal cancer compared to the general population and the incidence continues to increase despite better control of HIV infection with HAART (Highly Active Anti-Retroviral Therapy). The causative agent is known to be Human Papilloma Virus infection which can lead to dysplastic changes in the anus, detectable by High Resolution Anoscopy with biopsies. The analysis of the abnormal tissue can then be graded as Anal Intraepithelial Neoplasia 1 to 3, with AIN 2 or 3 considered as high grade dysplasia. These lesions are cancer precursors, but the proportion of lesions progressing to invasive anal cancer and the time to event are unknown. There is currently no recognized treatment to offer as standard of care although it is of general belief that treating these lesions, as it is done for women with CIN 2 and 3 (Cervical Intraepithelial Neoplasia) could help decrease the number of progressions to invasive anal cancer in MSM infected with HIV.
By experience at our center and results of this technique for other gastrointestinal pathologies, we believe Argon Plasma Coagulation (APC) could be a safe, well tolerated and efficient treatment of high-grade dysplasia (AIN 2/3) in HIV infected MSM.
This study will assess the APC treatment in 20 patients, all HIV infected MSM, with established AIN 2/3 (as confirmed with their last two anal biopsies, at least 4 months apart). Patients will then be followed with regular High Resolution Anoscopies for two years. The primary objective is to assess if APC is a safe and well tolerated treatment method for AIN 2/3 in HIV-positive MSM. As secondary objectives, the efficacy of APC treatment on AIN 2/3 lesions in HIV-positive MSM, the number of treatments with APC necessary to obtain regression or resolution of AIN 2/3 over two years and the efficacy of APC treatment to decrease anal HPV in this population will also be addressed.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65 years
- The last two High Resolution Anoscopies (HRA) of the patient, occurring at least 4 months apart, revealed histologic diagnoses of AIN 2 or 3
- HIV infected for at least 6 months
- Patient must be a man having sex with other men (currently or anteriorly).
- Able to provide a signed and dated Research Ethics Board (REB)-approved informed consent form (ICF) for the study
Exclusion Criteria:
- History of invasive anal cancer
- International normalized ratio (INR) > 1.5
- Platelet count < 50,000
- Previously (or currently) received chemotherapy or radiotherapy for AIN or anal cancer
- Currently receiving interferon or cidofovir treatment
- Diagnosed with circumferential (diffuse) high-grade AIN, or involving > 75% of the anal canal.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00428285
| Canada, Quebec | |
| Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal) | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Royal Victoria Hospital (McGill University Health Center) | |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Principal Investigator: | Alexandra de Pokomandy, MD | Centre hospitalier de l'Université de Montréal (CHUM) |
| Principal Investigator: | George Ghattas, MD | McGill University Health Center and Centre Hospitalier de l'Université de Montréal (CHUM) |
More Information
| Responsible Party: | Alexandra de Pokomandy, MD, Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT00428285 History of Changes |
| Other Study ID Numbers: | CTN-216 SL06-0.11 (CHUM) |
| Study First Received: | January 25, 2007 |
| Last Updated: | July 29, 2016 |
| Health Authority: | Canada: Canadian Institutes of Health Research Canada: Health Canada |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
Human Papilloma Virus HIV infected MSM Treatment Experienced Treatment Naive Anal Intraepithelial Neoplasia |
Additional relevant MeSH terms:
|
HIV Infections Neoplasms HIV Seropositivity Carcinoma in Situ Anus Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on September 30, 2016