Imagine being diagnosed with anal cancer while also living with HIV. It's a tough battle, as the immune system is already compromised, making treatment more complicated. This study is looking into new ways to tackle this challenge by testing different combinations of chemotherapy and immunotherapy. For patients with low-risk anal cancer, the focus is on using a gentler form of radiation and chemotherapy, while those with high-risk cancer will receive standard treatment followed by a powerful immunotherapy drug called nivolumab. The goal is to see if these approaches can not only keep cancer at bay but also improve the immune system's ability to fight off infections. While results are still pending, this research could lead to more effective and safer treatment options for those affected. However, it's important to remember that these treatments are still in the testing phase, and more research is needed to fully understand their benefits and risks. For now, patients can take heart knowing that advancements in treatment are on the horizon.
Can New Treatments Help Fight HIV-Related Anal Cancer More Effectively?
Plain Language Summary
What this means for you:
New treatment strategies may offer hope for better survival and fewer side effects in HIV-related anal cancer. What this means for you:
New treatment strategies may offer hope for better survival and fewer side effects in HIV-related anal cancer. View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): AIDS-Related Anal Carcinoma, Anal Margin Squamous Cell Carcinoma, Anal Non-Keratinizing Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, HIV Infection
Intervention(s): Anoscopy (PROCEDURE), Biospecimen Collection (PROCEDURE), Capecitabine (DRUG), Colonoscopy (PROCEDURE), Computed Tomography (PROCEDURE)
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.
Detailed: PRIMARY OBJECTIVES:
I. To determine the safety of reduced intensity chemo-radiation therapy (CRT) in low-risk disease.
II. To determine the safety of nivolumab after standard CRT in high-risk disease.
SECONDARY OBJECTIVES:
I. To estimate the efficacy (2-year disease-control rate \[DCR\]) of reduced intensity CRT in low risk disease.
II. To estimate the efficacy (2-year disease-free survival \[DFS\] rate) of nivolumab after standard CRT in high risk disease.
III. To evaluate the effect of low-dose CRT on immune function (CD4+ cell count) and human immunodeficiency virus (HIV) viral load.
IV. To evaluate the effect of nivolumab on immune function (CD4+ cell count) and HIV viral load.
V. To assess combination antiretroviral therapy (cART) adherence before, during, and after treatment
Primary Outcome(s): Incidence of adverse events (Low-risk stratum); Incidence of adverse events (High-risk stratum)
Enrollment: 40 (ESTIMATED)
Lead Sponsor: National Cancer Institute (NCI)
Start: 2022-08-09 | Primary Completion: 2031-09-15