Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Therapeutic vaccine, PD-1 knockout
Eligibility Criteria
Inclusion Criteria:
• Histologically confirmed prostate cancer (stage IV, according to NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 2.2017)
- Evidence of metastasis in the soft tissue and/or bone.
- Progressive androgen independent castrate resistant prostate cancer.
- Serum PSA ≥ 5.0 ng/mL
- Estimated life expectancy ≥ 6 months.
- Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
- Adequate hematologic, renal and liver function.
Exclusion Criteria:
• Presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
- Presence of moderate to severe pain treating with opioid analgesics within 21 days prior to registration.
- ECOG score ≥ 2.
- Any other systemic therapy for prostate cancer (except for medical castration).
- Participation in previous study using Provenge (Sipuleucel-T) or similar product.
- Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
- Known malignancies other than prostate cancer requiring active treatment within 6 months.
- A requirement for systemic immunosuppressive therapy for any reason.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to this product or granulocyte-macrophage colony-stimulating factor.
- Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
- Any medical intervention or other condition which, in the opinion of the Principal Investigator could compromise adherence with study requirements or otherwise compromise the study's objectives.
- Treatment with any of the following medications or interventions within 28 days of registration:
Systemic use of corticosteroids, External beam radiation therapy or surgery, Use of non-steroidal antiandrogens Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto, Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole, 5-alpha-reductase inhibitors, Treatment with any other investigational product Treatment with chemotherapy High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day). Initiation or discontinuation of bisphosphonate therapy
Sites / Locations
- First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting
- Professor Size ChenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Active Comparator
Therapeutic vaccine
Therapeutic vaccine plus PD-1 knockout
PD-1 knockout T cells
Therapeutic vaccine will be prepared ex vivo using the peripheral mononuclear cells from the patients and the vaccine (as maturated dendritic cells) will be infused back to the patients in 3 times with a 2-week interval.
Therapeutic vaccine and PD-1 knockout T cells will be prepared ex vivo using the white cells from the patients and the vaccine (as maturated dendritic cells) and maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
PD-1 knockout T cells will be prepared ex vivo using the white cells from the patients and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.