Surgery for Anal Cancer in HIV/AIDS Patients

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AIDS Malignancy Consortium

Must be taking: Antiretrovirals

Must not be taking: Anticoagulants, Chemotherapy

Disqualifiers: Anal cancer history, Systemic chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: Immediate

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies surgery to treat patients with small anal or perianal cancer who also have HIV. The surgery aims to safely remove the cancer with fewer side effects compared to other treatments. By cutting out the cancer, it helps prevent it from spreading or returning.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that ongoing use of certain anticoagulant therapies (blood thinners) other than aspirin or NSAIDs must be stopped for surgical procedures. If you are on systemic chemotherapy or radiation therapy that affects bone marrow, it may also need to be stopped.

Is surgery for anal cancer safe in HIV/AIDS patients?

The safety of surgery for anal cancer in HIV/AIDS patients is not well-documented in the available research, which mainly focuses on chemoradiotherapy. There is some uncertainty about increased toxicity and adverse effects on the immune system with standard treatments, but specific safety data for surgery alone is lacking. ^{1 2 3 4 5}

How does the treatment 'Therapeutic Conventional Surgery' for anal cancer in HIV/AIDS patients differ from other treatments?

Therapeutic Conventional Surgery for anal cancer in HIV/AIDS patients is unique because it involves a surgical approach, whereas the standard treatment for anal cancer typically involves chemoradiotherapy, which combines chemotherapy and radiation to preserve anal function and avoid more invasive surgery. This surgical method may be considered when chemoradiotherapy is not effective or suitable. ^{4 6 7 8 9}

Research Team

Stephen Goldstone

Principal Investigator

AIDS Associated Malignancies Clinical Trials Consortium

Eligibility Criteria

Adults with early stage anal canal or perianal cancer and HIV can join this trial. They should have a certain level of white blood cells, no history of other cancers, and be able to follow the study plan. Pregnant women can't participate, and men must use birth control if they could father a child.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

Life expectancy of 2 years or more

Leukocytes >= 3,000/mm^3

Exclusion Criteria

My current cancer treatment is affecting my bone marrow.

My SISCCA has not been removed or destroyed.

I haven't taken any experimental drugs in the last 4 weeks, except for HIV treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication.

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for treatment failure and adverse events every 3 months for 36 months.

36 months

12 visits (in-person)

Specimen Collection

Collection of clinical specimens for correlative science to assess viral and host factors in HSIL progression to cancer.

Up to 36 months

Treatment Details

Interventions

• Therapeutic Conventional Surgery

Trial Overview The trial is testing how safe and effective local surgery is for treating small, non-deeply spread anal cancers in patients with HIV. It aims to see if smaller surgeries have fewer side effects compared to larger ones or radiation and chemotherapy.

Participant Groups

Group I: Treatment (surgery) Experimental Treatment 1 Intervention

Participants undergo therapeutic conventional surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication in accordance with clinician and participant preference.

Therapeutic Conventional Surgery is already approved in United States, European Union for the following indications:

Approved in United States as Therapeutic Conventional Surgery for:

• Resectable p16+ Locally Advanced Oropharynx Cancer

Approved in European Union as Transoral Surgical Resection for:

• HPV-positive oropharyngeal cancer

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Recruited

9,600+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

AIDS and Cancer Specimen Resource

Collaborator

Trials

8

Recruited

990+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

HIV-infected individuals are at an increased risk for anal cancer and its precursor, anal HSIL, highlighting the need for effective screening and treatment strategies for these patients.

Current treatment options for anal cancer in HIV-positive patients show variability in outcomes, and there is a pressing need for prospective, controlled trials to improve treatment efficacy and reduce morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anal cancer and its precursors in HIV-positive patients: perspectives and management. Berry, JM., Palefsky, JM., Welton, ML.[2005]

In a study of six patients with HIV and invasive anal cancer, two patients achieved durable complete responses with a combination of chemotherapy and pelvic radiotherapy, indicating that this treatment can be effective for those with moderate immunosuppression and early-stage tumors.

However, the study also highlighted the risks, as two patients with more advanced disease died within six months, and moderate to severe skin reactions were common, suggesting that treatment outcomes can vary significantly based on the stage of cancer and the patient's immune status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermoid anal cancer in HIV infected patients. Bottomley, DM., Aqel, N., Selvaratnam, G., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

HIV Infection Is Associated With Poor Outcomes for Patients With Anal Cancer in the Highly Active Antiretroviral Therapy Era. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Anal cancer and its precursors in HIV-positive patients: perspectives and management. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of chemoradiotherapy for anal cancer in patients with HIV infection: oncological outcomes, immunological status, and the clinical course of the HIV disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

HIV positivity and anal cancer outcomes: A single-center experience. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Are there HIV-specific Differences for Anal Cancer Patients Treated with Standard Chemoradiotherapy in the Era of Combined Antiretroviral Therapy? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cancer of the anal canal. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Local tumor control and toxicity in HIV-associated anal carcinoma treated with radiotherapy in the era of antiretroviral therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Epidermoid anal cancer in HIV infected patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Invasive anal squamous-cell carcinoma in the HIV-positive patient: outcome in the era of highly active antiretroviral therapy. [2022]