Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery

NCT03899987 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: I 77318NCI-2019-01192
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well enteric-coated (EC) aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. EC Aspirin may help to keep the prostate cancer from coming back. Rintatolimod may stimulate the immune system and interfere with the ability of tumor cells to grow and spread. Interferon-alpha 2b may improve the body's natural response to infections and may slow tumor growth. It is not yet known how well rintatolimod, EC aspirin, and interferon-alpha 2b work in treating patients with prostate cancer undergoing surgery.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Count of tumor infiltrating CD8+ lymphocytes

  This will be assessed by the increase in the total number of tumor infiltrating CD8+ T cells in the radical prostatectomy specimen (measured as cell density of CD8+ cell by immunohistochemistry), comparing Arm A versus Arm B versus Arm C. Will be natural log transformed prior to analysis. The primary analysis will consist of testing the single degree of freedom planned contrast at alpha = .10 that the 3 treatment means are in the ratio of 3:2:1 (contrast coefficients 3, -2, -1) for groups A, B and C, respectively groups. If this test rejects the null hypothesis of no group differences, will proceed to estimate group means and pairwise differences between groups with 90% confidence intervals. Non-overlapping confidence intervals will serve as evidence of differential treatment effects.

  Up to 3 years

Secondary Outcomes (4)

• Pathologic response

  Up to 3 years

• Number of patients with Surgical margin positivity

  Up to 3 years

• PSA response

  Up to 3 years

• Incidence of treatment-related adverse events

  Up to 30 days post treatment

Study Arms (3)

Arm I (EC aspirin, interferon alpha, rintatolimod, surgery)

EXPERIMENTAL

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..

Drug: EC Aspirin; Procedure: Radical Prostatectomy; Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod

Arm II (EC aspirin, rintatolimod, surgery)

EXPERIMENTAL

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.

Drug: EC Aspirin; Procedure: Radical Prostatectomy; Drug: Rintatolimod

Arm III (radical prostatectomy)

ACTIVE COMPARATOR

Patients undergo radical prostatectomy about 4 weeks after enrollment.

Procedure: Radical Prostatectomy

Interventions

EC Aspirin DRUG

Given PO

Also known as: Acetylsalicylic Acid, ASA, Aspergum, aspirin, Ecotrin, Empirin, Entericin, Extren, Measurin, Enteric-coated aspirin

Arm I (EC aspirin, interferon alpha, rintatolimod, surgery); Arm II (EC aspirin, rintatolimod, surgery)

Radical Prostatectomy PROCEDURE

Undergo radical prostatectomy

Also known as: Prostatovesiculectomy

Arm I (EC aspirin, interferon alpha, rintatolimod, surgery); Arm II (EC aspirin, rintatolimod, surgery); Arm III (radical prostatectomy)

Recombinant Interferon Alfa-2b BIOLOGICAL

Given IV

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, Interferon Alfa-2B, Interferon Alpha-2b, Intron A, Sch 30500, Urifron, Viraferon

Arm I (EC aspirin, interferon alpha, rintatolimod, surgery)

Rintatolimod DRUG

Given IV

Also known as: Ampligen, Atvogen

Arm I (EC aspirin, interferon alpha, rintatolimod, surgery); Arm II (EC aspirin, rintatolimod, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, localized prostate adenocarcinoma patients who are planning to have a radical prostatectomy.
• Diagnostic prostate biopsy must have been obtained within 6 months patients who had biopsies at outside facilities may be eligible if tissue availability and adequacy can be confirmed by pathology.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Platelet \>= 75,000/uL.
• Hemoglobin \>= 9 g/dL.
• Hematocrit \>= 27%.
• Absolute neutrophil count (ANC) \>= 1500/uL.
• Creatinine \< institutional upper limit of normal (ULN) OR creatinine clearance \>= 50 mL/min for patients with creatinine levels greater than ULN.
• Total bilirubin =\< 1.5 X institutional ULN.
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 X institutional ULN.
• Serum amylase and lipase =\< 1.5 X institutional ULN.
• Negative hepatitis panel for patients with a history of Hepatitis
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

You may not qualify if:

• Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.
• Patients who received hormonal therapy, 5-alpha reductase inhibitors (such as finasteride, dutasteride), chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment.
• Patients with active prostatitis.
• Patients with active autoimmune disease or history of transplantation.
• Patients with comorbid medical conditions that render them unfit for surgery.
• Metastatic disease based on preoperative imaging.
• Cardiac risk factors including:
• Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent
• Patients with a New York Heart Association classification of III or IV.
• History of upper and lower gastrointestinal ulceration, upper gastrointestinal bleeding, or perforation within the past 3 years.
• History of bleeding disorders, known lesions at risk for bleeding, or history of recent clinically significant bleed or hemorrhage (\<3months).
• Prior allergic reaction or hypersensitivity to aspirin, or other nonsteroidal antiinflammatory drugs (NSAIDs).
• Patients are ineligible if they plan on use of other NSAIDs at any dose during the trial. Patients who agree to stop regular NSAIDs are eligible and no wash out period is required.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Unwilling or unable to follow protocol requirements.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: collaborator
• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Introns; Interferon alpha-2; poly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Gurkamal S Chatta

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 2, 2019
• Study Start: November 29, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)