Trials / Active Not Recruiting

Active Not RecruitingNCT03899987

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

Randomized Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment Using a Novel Chemokine-Modulating Regimen

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 12 (actual)

Sponsor: Roswell Park Cancer Institute · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Assess the immunomodulatory effectiveness of the combination of rintatolimod and EC aspirin with or without recombinant interferon alfa-2b (interferon \[IFN\]-alpha), in participants with localized prostate cancer undergoing radical prostatectomy. SECONDARY OBJECTIVES: I. Assess the safety and toxicity of the treatment combinations in participants with localized prostate cancer undergoing radical prostatectomy. II. Assess the antitumor activity between treatment arms. EXPLORATORY OBJECTIVES: I. Compare the resected tumor tissue specimen and surrounding tissue samples of both study arms (pre versus \[vs\] post-chemokine modulatory \[CKM\] treatment, with vs without CKM, CKM doublet vs CKM triplet) with regards to infiltrating T cell subtypes, effector T cell (Teff)/regulatory T cell (Treg) ratios, CD11b+ myeloid-derived suppressor cell (MDSC); the expression of chemokine receptors and immune checkpoint molecules on immune cells; local expression of Teff-attracting chemokines and Treg/MDSC-favoring chemokines; ribonucleic acid (RNA) signatures of groups of immune-regulatory genes that are modulated by the CKM regimen. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive EC aspirin orally (PO) two times a day (BID) from day -7 to 7 days prior to surgery. Patients also receive recombinant interferon alfa-2b intravenously (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. ARM II: Patients receive EC aspirin PO BID from day -7 to 7 days prior to surgery 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. ARM III: Patients undergo radical prostatectomy about 4 weeks after enrollment. After completion of study treatment, patients are followed up at 30 days.

Conditions

Interventions

Type	Name	Description
DRUG	EC Aspirin	Given PO
PROCEDURE	Radical Prostatectomy	Undergo radical prostatectomy
BIOLOGICAL	Recombinant Interferon Alfa-2b	Given IV
DRUG	Rintatolimod	Given IV

Timeline

Start date: 2019-11-29
Primary completion: 2025-06-12
Completion: 2026-11-29
First posted: 2019-04-02
Last updated: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03899987. Inclusion in this directory is not an endorsement.