Surgery for Anal Cancer in HIV/AIDS Patients

Not currently recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgery to treat small anal cancers in people living with HIV. The goal is to determine if a local surgery, known as Therapeutic Conventional Surgery, can effectively remove cancer with fewer side effects than larger surgeries or treatments like radiation and chemotherapy. It seeks participants diagnosed with small anal or perianal cancer that hasn't spread deeply and are HIV-positive. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that local surgery might be a safer choice for treating early-stage anal cancer compared to more extensive surgery or treatments like radiation and chemotherapy. Limited research exists specifically on surgery for patients with HIV. However, studies on early-stage anal cancer patients have found that local surgery alone can be effective. This procedure is generally well-tolerated and has fewer side effects than more aggressive treatments.

Although specific safety data for patients with HIV is limited, the smaller scale of the surgery suggests it could be a less risky option. For those considering joining a trial, it's important to know that the surgery aims to remove cancer with less impact on the body. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about therapeutic conventional surgery for anal cancer in HIV/AIDS patients because it aims for complete eradication of cancerous lesions, which is a step beyond the typical management strategies like chemoradiation or topical treatments. What sets this approach apart is its focus on not only removing the cancerous tissue but also addressing any remaining high-grade squamous intraepithelial lesions (HSIL), which are precursors to cancer. This comprehensive surgical method could potentially offer a more definitive solution, reducing the chances of recurrence and improving long-term outcomes for patients.

What evidence suggests that therapeutic conventional surgery might be an effective treatment for anal cancer in HIV/AIDS patients?

Research has shown that surgery can effectively treat small anal or perianal cancers, particularly in individuals with HIV. One study found that removing early-stage anal cancers through surgery successfully treated those living with HIV. Further evidence suggests that surgery can lead to favorable outcomes, with up to 89% of patients surviving for 5 years when the cancer is detected early and hasn't spread. This trial will evaluate the effectiveness of therapeutic conventional surgery for managing anal cancer in HIV-positive patients, potentially offering a safer method with fewer side effects compared to more aggressive treatments like chemotherapy and radiation. ^{2 6 7 8 9}

Who Is on the Research Team?

Stephen Goldstone

Principal Investigator

AIDS Associated Malignancies Clinical Trials Consortium

Are You a Good Fit for This Trial?

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 SISCCA has not been removed or destroyed.

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

My current cancer treatment is affecting my bone marrow.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/surgery-for-anal-cancer-in-hivaids-patients-21880

Surgery for Anal Cancer in HIV/AIDS Patients 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4974747/

Outcomes of abdominoperineal resection for management ... This study sought to describe the current outcome disparities between anal cancer patients with and without HIV undergoing abdominoperineal resection (APR).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798316003711

Surgical excision alone for stage T1 anal verge cancers in ... These new findings suggest that surgical resection for early stage anal verge cancers are also an effective strategy in PLWH.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7240186/

Squamous cell anal cancer: Management and therapeutic ... The 5-year survival rate is 89% in patients with early and local disease, falling to 12% in patients with distant metastases (Table 1). Male sex, positive lymph ...

5. jgo.amegroups.org jgo.amegroups.org/article/view/7/html_6

HIV– positive anal cancer: an update for the clinician The majority of patients (93%) diagnosed with anal cancer had been treated with antiretroviral therapy for over 6 months (12). Screening.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02437851

Surgery in Treating Patients With Early Stage Anal Canal ... Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27012999/

Surgical excision alone for stage T1 anal verge cancers in ... The risk of anal cancer is higher in people living with HIV (PLWH). We present results of the outcomes of T1 anal verge cancers treated by local excision only ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04929028

UCSF Anal Cancer Trial → Therapy Adapted for High Risk ... This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2201048

Treatment of Anal High-Grade Squamous Intraepithelial ... Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring.