Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Brief Title

Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

Official Title

Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study

Brief Summary

      RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer
      in patients who have anal neoplasia.

      PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal
      cancer in HIV-positive patients who have high-grade anal neoplasia.
    

Detailed Description

      OBJECTIVES:

        -  Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the
           anal canal of HIV-positive patients treated with infrared coagulation.

        -  Determine the time to recurrence and time to progression in patients treated with this
           procedure.

        -  Determine the toxicity of this procedure in these patients.

        -  Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this
           procedure.

        -  Correlate outcome with human papilloma virus subtype in patients treated with this
           procedure.

      OUTLINE: This is an open-label, pilot, multicenter study.

      Patients undergo treatment with an infrared coagulator in direct contact with the lesion for
      1.5 seconds and necrotic tissue is then debrided. Treatment repeats to the level of the
      submucosal vessels under colposcopic guidance. A repeat biopsy is performed at 3 months to
      assess treatment success. Patients with incompletely treated lesions receive 1 more
      treatment. Up to 3 lesions are treated during each visit in the absence of disease
      progression or unacceptable toxicity.

      Patients complete questionnaires regarding anal pain and discomfort at baseline, at 4 weeks,
      and at 3, 6, 9, and 12 months.

      Patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 6 months.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Anal Cancer

Intervention

infrared photocoagulation therapy

Study Arms / Comparison Groups

 Infrared coagulator
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

18

Start Date

September 2003

Completion Date

April 2006

Primary Completion Date

September 2004

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  HIV positive

          -  Presence of internal anal lesions with histologically confirmed high-grade squamous
             intraepithelial neoplasia with at least 1 positive margin

               -  No more than 3 lesions, each no more than 10 mm in diameter

          -  No evidence of microscopic invasion in any anal biopsy specimens

          -  No history of anal cancer

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  Karnofsky 70-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count at least 50,000/mm^3

          -  CD4 count at least 50 cells/mm^3

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No allergy to lidocaine

          -  No anal insertions, including enemas or anal intercourse, for 24 hours before and at
             least 1 week after study treatment

          -  No prior severe photosensitivity reaction

          -  No active opportunistic infection

          -  No concurrent neoplasia requiring cytotoxic therapy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  Must be on stable regimen of highly active antiretroviral therapy (HAART) for at least
             12 weeks prior to study entry unless CD4 count > 200/mm^3 AND no plans to initiate
             HAART within the next 3 months

          -  More than 14 days since prior acute treatment for an infection or other medical
             illness

          -  No prior infrared coagulation for anal dysplasia
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elizabeth Stier, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00066430

Organization ID

AMC-032

Secondary IDs

CDR0000316109

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Elizabeth Stier, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

September 2014