NCT00066430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2003

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

August 6, 2003

Last Update Submit

September 16, 2014

Conditions

Anal CancerPrecancerous Condition

Keywords

anal cancerhigh-grade squamous intraepithelial lesion

Study Arms (1)

Infrared coagulator

EXPERIMENTAL
Procedure: infrared photocoagulation therapyDevice: Infrared Coagulator

Interventions

infrared photocoagulation therapyPROCEDURE
Infrared coagulator
Infrared CoagulatorDEVICE

IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.

Also known as: Redfield Infrared Coagulator (IRC) 2100
Infrared coagulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Anus NeoplasmsPrecancerous ConditionsSquamous Intraepithelial Lesions

Interventions

Light Coagulation

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsHemostasis, SurgicalSurgical Procedures, OperativeOphthalmologic Surgical Procedures

Study Officials

  • Elizabeth Stier, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

September 1, 2003

Primary Completion

September 1, 2004

Study Completion

April 1, 2006

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

US(2)