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

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.

Conditions

• AIDS-Related Anal Carcinoma
• Anal Margin Squamous Cell Carcinoma
• Anal Non-Keratinizing Squamous Cell Carcinoma
• Anal Squamous Cell Carcinoma
• HIV Infection
• Rectal Squamous Cell Carcinoma
• Stage II Rectal Cancer AJCC v8
• Stage IIB Anal Cancer AJCC v8
• Stage III Anal Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8

Interventions

OTHER

Fludeoxyglucose F-18

Receive FDG

DRUG

Fluorouracil

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Lymph Node Biopsy

Undergo lymph node biopsy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI or PET/MRI

DRUG

Mitomycin

Given IV

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG PET/CT or PET/MRI

PROCEDURE

Proctoscopy

Undergo proctoscopy

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Sigmoidoscopy

Undergo sigmoidoscopy

PROCEDURE

Anoscopy

Undergo anoscopy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Capecitabine

Given PO

PROCEDURE

Colonoscopy

Undergo colonoscopy

PROCEDURE

Computed Tomography

Undergo CT or FDG PET/CT

PROCEDURE

Digital Rectal Examination

Undergo digital rectal exam

PROCEDURE

Echocardiography Test

Undergo ECHO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Rafi Kabarriti · AIDS Malignancy Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-09

Primary Completion

2031-09-15

Completion

2031-09-15

FDA Drug

Yes

Countries

• United States

Study Locations