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

Part of paid clinical trials in San Francisco, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04929028
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anoscopy — PROCEDURE
    Undergo anoscopy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Capecitabine — DRUG
    Given PO
  • Colonoscopy — PROCEDURE
    Undergo colonoscopy
  • Computed Tomography — PROCEDURE
    Undergo CT or FDG PET/CT
  • Digital Rectal Examination — PROCEDURE
    Undergo digital rectal exam
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Fludeoxyglucose F-18 — OTHER
    Receive FDG
  • Fluorouracil — DRUG
    Given IV
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Lymph Node Biopsy — PROCEDURE
    Undergo lymph node biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI or PET/MRI
  • Mitomycin — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG PET/CT or PET/MRI
  • Proctoscopy — PROCEDURE
    Undergo proctoscopy
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Sigmoidoscopy — PROCEDURE
    Undergo sigmoidoscopy

Study Details

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.

Key Dates

Start date
Aug 9, 2022
Status verified
Apr 2026
Primary completion
Sep 15, 2031
Completion
Sep 15, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-risk stratum (nivolumab)
    Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening as clinically indicated, sigmoidoscopy/colonoscopy, anoscopy/proctoscopy or digital rectal exam and CT throughout the study as well as blood sample collection during screening and EOT.
  • Experimental: Low-risk stratum (mitomycin
    Patients receive mitomycin IV on day 1 and either fluorouracil IV on day 1 or capecitabine PO BID on Monday-Friday until the completion of radiation therapy at the discretion of the treating physician. Patients also undergo IMRT QD for 20-23 treatment sessions over 6 weeks. Patients also undergo digital rectal exam, anoscopy/proctoscopy and CT throughout the study, receive FDG IV and undergo PET/CT, PET/MRI and /or MRI during screening and follow-up as well as blood sample collection during screening and EOT. Some patients undergo lymph node biopsy during screening at the discretion of the treating physician.

Primary Outcome Measure

Incidence of adverse events (Low-risk stratum) [ Time Frame: Up to 5 years ]

Locations (14)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110-
George Washington University Medical CenterWashington D.C.District of Columbia20037-
Moffitt Cancer CenterTampaFlorida33612-
University of IllinoisChicagoIllinois60612-
Washington University School of MedicineSt LouisMissouri63110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Mount Sinai HospitalNew YorkNew York10029-
Mount Sinai WestNew YorkNew York10019-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Pennsylvania HospitalPhiladelphiaPennsylvania19107-
Lyndon Baines Johnson General HospitalHoustonTexas77026-1967-
UT MD Anderson Cancer CenterHoustonTexas77030-
Virginia Mason Medical CenterSeattleWashington98101-

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