RecruitingPhase 2NCT04929028

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Risk-Adapted Therapy for HIV-Associated Anal Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

40 participants

Start Date

Aug 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adjusting the intensity of radiation and chemotherapy treatment based on cancer risk level leads to better outcomes for HIV-positive people with anal cancer. **You may be eligible if...** - You are HIV-positive - You have been diagnosed with squamous cell carcinoma of the anus (a type of anal cancer) - Your cancer is at a specific stage (either high-risk locally advanced, or lower-risk) - You are planning to start or have recently started chemotherapy with radiation **You may NOT be eligible if...** - You do not have a confirmed diagnosis of anal canal squamous cell cancer - Your HIV infection is not being managed or documented - You have other major health conditions that would make treatment unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAnoscopy

Undergo anoscopy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCapecitabine

Given PO

PROCEDUREColonoscopy

Undergo colonoscopy

PROCEDUREComputed Tomography

Undergo CT or FDG PET/CT

PROCEDUREDigital Rectal Examination

Undergo digital rectal exam

PROCEDUREEchocardiography Test

Undergo ECHO

OTHERFludeoxyglucose F-18

Receive FDG

DRUGFluorouracil

Given IV

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURELymph Node Biopsy

Undergo lymph node biopsy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI or PET/MRI

DRUGMitomycin

Given IV

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo FDG PET/CT or PET/MRI

PROCEDUREProctoscopy

Undergo proctoscopy

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESigmoidoscopy

Undergo sigmoidoscopy


Locations(14)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Illinois

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mount Sinai West

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Lyndon Baines Johnson General Hospital

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04929028


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