Study on Tailored Treatment for High and Low Risk HIV-Associated Anal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04929028

Provider View

This clinical trial is exploring the effects of chemotherapy and radiation therapy for patients with low-risk HIV-associated anal cancer, and the addition of the immunotherapy drug nivolumab for those with high-risk HIV-associated anal cancer. The study aims to determine if these treatments can effectively control the cancer and reduce the risk of it returning.

Patient Parameters

Program Overview

This study is investigating how well chemotherapy and radiation therapy work for patients with low-risk HIV-associated anal cancer, and whether adding the immunotherapy drug nivolumab can help patients with high-risk HIV-associated anal cancer. Chemotherapy and radiation aim to kill cancer cells, while nivolumab may help the immune system attack the cancer. The study will look at the safety and effectiveness of these treatments and their impact on the immune system and HIV management.

Description

The study is divided into two groups based on the risk level of the cancer:

  • High-Risk Group: Patients will receive the immunotherapy drug nivolumab through an IV every four weeks for up to six cycles, as long as the cancer does not progress and side effects are manageable.

  • Low-Risk Group: Patients will receive chemotherapy drugs (mitomycin and either fluorouracil or capecitabine) along with radiation therapy. The chemotherapy will be given either through an IV or orally, and radiation will be administered daily for 20-23 sessions over six weeks.

After completing the treatment, patients will have follow-up visits at 6 weeks, every 3 months for the first 2 years, every 6 months in the third year, and annually for years 4 and 5.

The study will also explore how these treatments affect the immune system, HIV management, and quality of life. Researchers will look at the relationship between specific HPV types and treatment response, as well as the presence of HPV DNA in the blood before and after treatment.

Eligibility Criteria

Inclusion Criteria

  • High-Risk Group:

    • Must be able to understand and sign a consent form.
    • Must have a confirmed diagnosis of high-risk anal cancer.
    • Must be HIV-positive and on stable antiretroviral therapy.
    • Must be 18 years or older.
    • Must have a life expectancy of more than 6 months.
    • Must have adequate blood counts and organ function.
    • Women of childbearing potential must agree to use contraception.
    • Must have a CD4 count of at least 100 cells/uL.
    • Must have received prior radiation therapy for anal cancer.

  • Low-Risk Group:

    • Must be able to understand and sign a consent form.
    • Must have a confirmed diagnosis of low-risk anal cancer.
    • Must be HIV-positive and on stable antiretroviral therapy.
    • Must be 18 years or older.
    • Must have a life expectancy of more than 6 months.
    • Must have adequate blood counts and organ function.
    • Women of childbearing potential and sexually active men must agree to use contraception.
    • Must have a CD4 count of at least 100 cells/uL.

Exclusion Criteria

  • High-Risk Group:

    • Recent live vaccines.
    • Symptomatic lung disease.
    • Prior treatment with certain immune therapies.
    • Recent organ transplant.
    • Allergies to study drugs.
    • Uncontrolled illnesses or infections.
    • History of another cancer unless disease-free for 2 years.
    • Pregnant or breastfeeding women.
    • Unrecovered side effects from previous treatments.
    • Autoimmune diseases requiring treatment.
    • Recent surgery.

  • Low-Risk Group:

    • Prior surgery for anal cancer.
    • Receiving other cancer treatments.
    • Significant heart disease.
    • Prior chemotherapy for anal cancer.
    • Pregnant or breastfeeding women.

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