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Chemotherapy

Chemotherapy + Radiation for HIV-Associated Anal Cancer

New York, NY
Phase 2
Recruiting
Led By Rafi Kabarriti
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have =< grade 2 diarrhea
Participant must have histologically proven stage (T3-T4N0M0 OR T2-4N1M0) invasive squamous cell carcinoma (SCC) of the anus or anorectum as documented before CRT initiation, according to the American Joint Committee on Cancer (AJCC) 8th edition. Participants with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal. Participants with tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology are permitted
Must not have
Participant requires steroid treatment or other immunosuppressive treatment
Participant with an allogenic bone marrow/stem cell or solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the effects of chemotherapy, radiation, and immunotherapy in treating HIV-associated anal cancer. It targets both low-risk and high-risk patients, aiming to kill cancer cells and help the immune system prevent the cancer from coming back.

Who is the study for?
This trial is for adults with HIV-associated anal cancer. Low-risk patients have T1-2N0M0 tumors ≤4 cm, while high-risk patients have stage T3-T4N0M0 or T2-4N1M0 tumors. All must understand the study, sign consent, have a life expectancy over 6 months, adequate blood counts and organ function, be on stable HIV treatment with controlled viral load, agree to contraception if applicable, and not be pregnant or breastfeeding.
What is being tested?
The trial tests chemotherapy (mitomycin, fluorouracil/capecitabine) combined with intensity-modulated radiation therapy for low-risk anal cancer patients. High-risk patients receive standard care plus nivolumab post-treatment to reduce tumor recurrence risk. Nivolumab is an immunotherapy that may help the immune system fight cancer more effectively.
What are the potential side effects?
Chemotherapy can cause nausea, fatigue, hair loss and increased infection risk. Radiation might lead to skin irritation and fatigue. Nivolumab could result in immune-related side effects like inflammation of organs such as lungs or intestines and potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diarrhea is mild or moderate.
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I have a specific type of anal cancer that is at a certain stage and has not spread to distant parts of my body.
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I can take care of myself but might not be able to do heavy physical work.
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I am on a consistent HIV medication regimen.
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I have received radiation therapy for anal cancer.
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I am 18 years old or older.
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I have tested negative for tuberculosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need steroids or other drugs that lower my immune system.
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I have had a bone marrow/stem cell or organ transplant from another person.
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I had surgery aimed at curing anal cancer.
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I have a history of cancer.
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I had a different cancer within the last 2 years.
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I have been treated with drugs that boost the immune system.
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I have been diagnosed with interstitial lung disease.
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I have received chemotherapy for my cancer before.
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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (High-risk stratum)
Incidence of adverse events (Low-risk stratum)
Secondary study objectives
Change in CD4+ cell counts (High-risk stratum)
Change in combination antiretroviral therapy (cART) adherence
Change in human immunodeficiency virus (HIV) viral load (Low-risk stratum)
+2 more
Other study objectives
Effect of reduced intensity CRT and nivolumab on viral HIV reservoirs
Impact of reduced intensity CRT on quality of life
Prevalence of cell-free plasma HPV deoxyribonucleic acid (DNA) before and after reduced intensity CRT and nivolumab
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low-risk stratum (mitomycinExperimental Treatment17 Interventions
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.
Group II: High-risk stratum (nivolumab)Experimental Treatment10 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anoscopy
2015
N/A
~10
Echocardiography
2013
Completed Phase 4
~11580
Fluorouracil
2014
Completed Phase 3
~11700
Sigmoidoscopy
2007
Completed Phase 2
~140
Colonoscopy
2012
Completed Phase 3
~115560
Lymph Node Biopsy
2014
Completed Phase 2
~50
Proctoscopy
2012
Completed Phase 1
~10
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biospecimen Collection
2004
Completed Phase 3
~2030
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nivolumab
2015
Completed Phase 3
~4010
Computed Tomography
2017
Completed Phase 2
~2790
Mitomycin
2009
Completed Phase 3
~410
Capecitabine
2013
Completed Phase 3
~4280
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Anal Carcinoma include chemotherapy, radiation therapy, and immunotherapy with monoclonal antibodies such as Nivolumab. Chemotherapy uses drugs like mitomycin, fluorouracil, and capecitabine to kill cancer cells, stop their division, or prevent their spread. Radiation therapy employs high-energy x-rays to destroy tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as Nivolumab, enhances the body's immune system to attack cancer cells and may inhibit tumor growth and spread. These treatments are often combined to maximize their effectiveness, offering a comprehensive approach to managing Anal Carcinoma and potentially reducing the risk of recurrence.
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Find a Location

Closest Location:Mount Sinai Hospital· New York, NY

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,955 Previous Clinical Trials
41,111,921 Total Patients Enrolled
Rafi KabarritiPrincipal InvestigatorAIDS Malignancy Consortium

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04929028 — Phase 2
Anal Carcinoma Research Study Groups: High-risk stratum (nivolumab), Low-risk stratum (mitomycin
Anal Carcinoma Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04929028 — Phase 2
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929028 — Phase 2
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