A neoadjuvant immunologic study of androgen deprivation therapy combined with a GM-CSFâ??secreting allogeneic prostate cancer vaccine and low-dose cyclophosphamide in men with high-risk localized prostate cancer undergoing radical prostatectomy
The purpose of this study is to find out: -If the GVAX prostate cancer vaccine is safe when given in combination with intravenous cyclophosphamide to men who will undergo prostate surgery and who have also received treatment with hormonal therapy -What effect GVAX and cyclophosphamide may have on anti-cancer immune responses in the prostate gland (in other words, to see if the vaccine can help the bodyï¿½s immune system recognize and attack its own prostate cancer cells) -How GVAX and cyclophosphamide may affect prostate-specific antigen levels after prostate surgery (PSA: a blood test that measures a protein released by prostate cancer) -How GVAX and cyclophosphamide may affect other markers of prostate cancer
Inclusion criteria: - histologically confirmed prostate adenocarcinoma - clinical stage T1cï¿½T3b, N0, M0 - prior decision to undergo radical prostatectomy at Johns Hopkins Hopsital - adult male greater than 21 years of age - good physical status - adequate kidney, liver, and bone marrow function - willingness to sign informed consent and adhere to study requirements Exclusion criteria: - presence of known lymph node involvement or distant metastases - prior radiation, hormones, biologics, or chemotherapy for prostate cancer - prior immunotherapy/vaccine therapy for prostate cancer - previous or concurrent use of cyclophosphamide - concomitant treatment with hormonal therapy or 5-reductase inhibitors - use of experimental agents for prostate cancer within the past 3 months - known allergy to cyclophosphamide or G-CSF/GM-CSF - known sensitivity to materials of bovine origin - history of autoimmune disease requiring systemic immunosuppression - other concurrent malignancy - uncontrolled major infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
This is a single-center, randomized, 2-arm, open-label, prospective clinical trial evaluating the immunogenicity and safety of a single administration of LHRH antagonist (degarelix) used alone, or degarelix administered following vaccination with low-dose cyclophosphamide and GVAX, given 4 weeks prior to radical prostatectomy in men with localized prostate cancer. Patients will be recruited from the outpatient Urology clinic. Eligible patients will be randomized to receive one of two treatment regimens, each beginning 28 (Â±2) days prior to radical prostatectomy. In Arm B, Cyclophosphamide will be given on Day 1 at a dose of 200 mg/m2 as a single intravenous infusion over 30 minutes. One day later, on Day 2, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 and five 0.5-mL intradermal injections of LNCaP. 1 - 2 hours prior to the injections on Day 2, Emla cream may be applied to the injection sites to help ease any injection discomfort. On day 14, Degarelix acetate will be administered as three 80-mg subcutaneous injections, for a total dose of 240 mg. The radiacal prostatectomy will take place 14 days (Â±2)later. Tissue from the prostate will be taken and examed to see how well the vaccines worked. In Arm A, an identical dose of degarelix acetate will be administered, 14 (Â±2) days prior to surgery.
05/20/2013 04:02 AM