Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate C… (NCT03899987) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery
United States12 participantsStarted 2019-11-29
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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.
* 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.
Exclusion Criteria:
* Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.
* Patients who receive…