NCT02153918已完成2 期
A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates
研究概览
简要总结
Background:
- Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence.
Objective:
- To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland.
Eligibility:
- Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment.
Design:
- Participants will be screened by their regular cancer care. They may have a small piece of prostate removed.
- Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster.
- Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities.
- Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.
- Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks.
- At each booster visit, participants will have a medical history, physical exam, and blood and liver tests.
- Participants will have another MRI. Then they will have surgery to remove their prostate.
- Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.
详细描述
Background
- Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.
- Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.
- A neoadjuvant approach may be of potential benefit providing prolonged protection via the patient s immune system against future recurrence.
- PROSTVAC is a vaccine that induces strong immune responses, has shown promising evidence of activity in a randomized phase II study (8.5 month improvement in median overall survival) and is currently in phase III clinical testing.
- This vaccine has been tested in locally recurrent prostate cancer with substantial inflammatory infiltrates within the prostate seen following subcutaneous and intraprostatic injection.
Objectives
-The primary objective is to evaluate the post vaccine immunologic cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cell infiltrate response of a neoadjuvant vaccine strategy in prostatectomy specimens in patients who plan to undergo radical prostatectomy.
Eligibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA
- •Patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis. If evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study as an alternative to having available tissue available.
- •Patients must be a surgical candidate for radical prostatectomy based on standard workup of prostatic specific antigen (PSA), biopsy results, and if necessary supplemental imaging.
- •Patients must have chosen radical prostatectomy as their definitive treatment of choice for management of their prostate cancer.
- •Patients must have a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG) criteria
- •No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.
- •Hematological eligibility parameters (within one month of starting therapy):
- •Granulocyte count greater than or equal to 1,500/mm(3)
- •Platelet count greater than or equal to 50,000/mm(3)
- •Hemoglobin (Hgb) greater than or equal to 8 g/dL
- •Biochemical eligibility parameters (within one month of starting therapy):
- •Hepatic function: Bilirubin < 1.5 mg/dl (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal.-. Creatinine less than or equal to 1.5 X ULN
- •Creatinine less than or equal to 1.5 X ULN
- •Patients must be test negative for human immunodeficiency virus (HIV), Hepatitis B and C.
- •Patients must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) or life threatening illnesses.
- •Patients must be willing to travel to the study site for follow-up visits.
- •Patients must be greater or equal to18 years of age.
- •All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of allergy to the vaccine.
- •Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.
- •The effects of the study agents used in this protocol on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (abstinence,vasectomy, or female partner use of intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation) prior to study entry and for up to one month after the last vaccination.
排除标准
- •Prior splenectomy.
- •The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):
- •Persons with active or a history of eczema or other eczematoid skin disorders
- •Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
- •Pregnant or nursing women; children under 3 years of age
- •Patients should have no evidence, as listed below, of being immunocompromised:
- •HIV positivity due to the potential for decreased tolerance and risk for severe side effects.
- •Hepatitis B or C positivity.
- •Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.
- •Patients with known allergy to eggs.
- •Other serious intercurrent illness.
- •Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
- •Patients with significant autoimmune disease that is active or potentially life threatening if activated.
- •Patients with clinically significant cardiomyopathy requiring treatment.
研究组 & 干预措施
Vaccine Plus Booster Shots
Experimental
PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
干预措施: PROSTVAC-V/TRICOM (Biological)
Vaccine Plus Booster Shots
Experimental
PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
干预措施: PROSTVAC-F/TRICOM (Biological)
结局指标
主要结局
Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates
时间窗: Baseline (pre vaccination) and approximately week 10
Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.
次要结局
- Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining(Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10)
- Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination(Baseline (pre vaccination) and approximately week 10)
- Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination(Baseline (pre vaccination) and approximately week 10)
- Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)(Date treatment consent signed to date off study, approximately 33 months and 5 days)
- Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses(Baseline (pre vaccination) and week 10)
研究者
Peter Pinto, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate CancerCastrate Sensitive Prostate CancerNCT03860987National Cancer Institute (NCI)12
招募中
2 期
Prospects of postoperative prostate cancer adaptive radiation therapyC61Malignant neoplasm of prostateDRKS00033235Klinik und Poliklinik für Strahlentherapie des Universitätsklinikums Essen29
进行中（未招募）
2 期
A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.Recurrent prostate cancerCancer - ProstateACTRN12615001183572Icon Cancer Foundation110
已完成
2 期
Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate BiopsyProstatic NeoplasmsNCT00152789University Health Network, Toronto40
终止
2 期
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate CancerProstatic NeoplasmsProstate CancerNCT02362451National Cancer Institute (NCI)7