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

Recruiting in Palo Alto (17 mi)

Overseen byGurkamal S Chatta

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This phase II trial studies how well aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. 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, aspirin, and interferon-alpha 2b work in treating patients with prostate cancer undergoing surgery.

Eligibility Criteria

Inclusion Criteria

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.

+7 more

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (aspirin, rintatolimod, surgery)Experimental Treatment3 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 (aspirin, interferon alpha, rintatolimod, surgery)Experimental Treatment4 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 Control1 Intervention

Patients undergo radical prostatectomy about 4 weeks after enrollment.