Aspirin + Rintatolimod ± Interferon-alpha 2b for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Immunosuppressants, Steroids, NSAIDs, others

Disqualifiers: Active prostatitis, Autoimmune disease, Metastatic disease, Cardiac risk, 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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a combination of aspirin, rintatolimod (an experimental treatment), and possibly interferon-alpha 2b in treating prostate cancer before surgery. The goal is to determine if these treatments can prevent cancer recurrence and enhance the immune system's ability to fight the cancer. The study involves different groups testing various combinations of the treatments, including a group undergoing only surgery. Men with localized prostate cancer planning surgery are suitable candidates, particularly if they have recently undergone a prostate biopsy. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

If you are taking systemic immunosuppressive agents or NSAIDs (nonsteroidal anti-inflammatory drugs), you will need to stop them before joining the trial. For NSAIDs, you can join if you agree to stop taking them, and no specific waiting period is required.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of aspirin and rintatolimod, with or without interferon-alpha 2b, is generally safe for patients. In past studies, serious side effects occurred in only about 5% of participants, indicating that most people can take the treatment without major issues. Aspirin, commonly used and FDA-approved for other purposes, supports its safety profile. Rintatolimod has been researched for its potential to strengthen the immune system. Although this trial remains in the early stages, existing evidence offers some reassurance about the safety of these treatments in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine rintatolimod with other agents like aspirin and interferon-alpha 2b, which offer a novel approach to tackling prostate cancer. Unlike traditional treatments such as hormone therapy, chemotherapy, or surgery alone, rintatolimod works by boosting the immune system to recognize and attack cancer cells. This immune activation method could potentially enhance the effectiveness of surgery. Additionally, the combination with aspirin, known for its anti-inflammatory properties, and interferon-alpha 2b, which has antiviral and anticancer effects, offers a comprehensive attack on the cancer, potentially improving outcomes and speeding up recovery times.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

In this trial, participants will receive different combinations of treatments to evaluate their effectiveness in treating prostate cancer. Research suggests that combining aspirin and rintatolimod may aid in treating prostate cancer. Aspirin might help prevent the cancer from returning, while rintatolimod could boost the immune system, potentially stopping the cancer from growing and spreading. In one arm of this trial, participants will receive aspirin, rintatolimod, and interferon-alpha 2b, which may further strengthen the body's natural defenses and possibly slow the cancer even more. Early studies indicate these treatments might work well together, but more research is needed to confirm their effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Gurkamal S Chatta

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men with localized prostate adenocarcinoma who are planning surgery. They must have had a biopsy within the last 6 months, be relatively healthy (ECOG status of 0 or 1), and have normal blood counts and liver function tests.

Inclusion Criteria

I have prostate cancer and am planning to undergo surgery to remove my prostate.

Platelet >= 75,000/uL.

Hemoglobin >= 9 g/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EC aspirin, rintatolimod, and possibly interferon-alpha 2b before undergoing radical prostatectomy

3-4 weeks

Multiple visits for IV administration and surgery

Surgery

Participants undergo radical prostatectomy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Recombinant Interferon Alfa-2b
• Rintatolimod

Trial Overview The study is testing if EC Aspirin and Rintatolimod, with or without Interferon-alpha 2b, can prevent prostate cancer from returning when given before surgery. It's unclear how well these treatments work together to treat patients undergoing prostatectomy.

How Is the Trial Designed?

Group I: Arm II (EC aspirin, rintatolimod, surgery) Experimental Treatment 3 Interventions

Patients receive aspirin PO BID on days -7 to 7 and rintatolimod IV over 2 hours on days 1-3,and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.

Group II: Arm I (EC aspirin, interferon alpha, rintatolimod, surgery) Experimental Treatment 4 Interventions

Patients receive aspirin PO BID on days -7 to 7. Patients also receive recombinant interferon alfa-2b IV over 20 minutes and rintatolimod IV over 2 hours on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24..

Group III: Arm III (radical prostatectomy) Active Control 1 Intervention

Patients undergo radical prostatectomy about 4 weeks after enrollment.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

AIM ImmunoTech Inc.

Industry Sponsor

Trials

15

Recruited

710+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4049786/

Aspirin improves outcome in high risk prostate cancer ... Median follow-up was 56.6 mo for all patients. For patients taking any AC compared with no AC, there was improved FFBF at 5 years of 80% vs. 62% ...

2. aimimmuno.com aimimmuno.com/wp-content/uploads/2024/11/AIM-12-31-2023-10K-pdf.pdf

UNITED STATES SECURITIES AND EXCHANGE ... Grade 3 or higher adverse events were rare (5%). • Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-01192

Aspirin and Rintatolimod with or without Interferon alfa-2b ... This phase II trial studies how well aspirin and rintatolimod with or without interferon alfa-2b work in treating patients with prostate cancer before ...

4. sigma.larvol.com sigma.larvol.com/ott.php?e1=412783&e2=&sourcepg=TZ&itype=0,1

Online Trial Tracker Results from trial in combination with Ampligen. Mar 2022 - Mar 2022: Results from trial in combination with Ampligen. Active, not recruiting. 1/2. 24. US.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3526345/

Aspirin use after a prostate cancer diagnosis and cancer ... Experimental and clinical data suggest that aspirin and other non-steroidal inflammatory drugs may delay the progression of prostate cancer through inhibition ...

6. sec.gov sec.gov/Archives/edgar/data/946644/000149315219013823/forms-1.htm

securities and exchange commission Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon ...