NCT02326805已完成2 期
Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients With Clinically Localized Prostate Cancer Undergoing Active Surveillance
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 14
- 主要终点
- Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
研究概览
简要总结
This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of rilimogene-galvacirepvec (PROSTVAC) on the change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
II. To determine the effect of PROSTVAC on the change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
SECONDARY OBJECTIVES:
I. To assess the effect of PROSTVAC on PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core, either random or targeted, in the most recent biopsy
- •All prior biopsies must meet the following: =< 50% of the total number of random biopsy cores positive for cancer
- •Gleason score =< (3+4)
- •Clinical stage =< T2a by digital rectal exam (DRE)
- •Biopsies performed at outside institutions should have Gleason score confirmed at the study site by a genitourinary (GU) pathologist to ensure eligibility
- •Pre-intervention biopsy tissue (most proximal to enrollment) with sufficient tumor tissue to cut 5-10 unstained slides confirmed to be available upon request
- •Screening serum PSA < 20 ng/mL; for men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL
- •Neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL)
- •Stable platelet count >= 75,000/mm^3 (>= 75 k/uL)
- •Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)
- •Serum creatinine =< 1.5 x ULN
- •Karnofsky >= 70%
- •Must agree to use medically acceptable barrier and/or chemical method of contraception while on study and for at least one month following the last vaccine injection; should a participant's partner become pregnant or suspect she is pregnant while the participant is participating in this study, the study physician should be informed immediately; in the event a participant's partner becomes pregnant, the study sponsor may request additional information regarding the course of the pregnancy and if the pregnancy is carried to term, the birth of the child (i.e., the outcome of the pregnancy)
- •Ability to understand and the willingness to sign a written informed consent document
- •No planned prostate biopsies during the intervention until after the post-intervention biopsy
- •Men on stable doses of 5-alpha reductase inhibitors are eligible as long as there is no planned dose change while on study
排除标准
- •Have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy
- •Patients who have prostate cancer with distant metastases
- •Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years
- •Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient; such illnesses/conditions may include, but are not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Positive for human immunodeficiency virus (HIV) or active infections for hepatitis B, and/or hepatitis C, based on medical history
- •Prior solid organ or bone marrow transplant
- •Immunodeficiency or splenectomy
- •Chronic immunosuppressive therapy within 30 days of screening
- •Inflammatory eye disease requiring steroid treatment within 28 days of screening
- •Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC-V/F; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
- •History of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome; persons with vitiligo are not excluded; Persons with well-controlled autoimmune endocrinopathies, e.g., diabetes mellitus, Graves' disease, Hashimoto's thyroiditis, Addison's disease are not excluded; persons with well-controlled rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica are not excluded
- •Known allergy to eggs, egg products
- •Prior or concurrent eczema or other eczemoid skin disorders or active skin condition (acute, chronic, or exfoliative) that disrupts the epidermis; persons with psoriasis are not excluded except in cases of:
- •any active lesion
- •any active lesion in the previous 6 months that required treatment, either systemic or topical
- •any prior episode, at any time, extensive enough or severe enough as to require systemic treatment
- •Previous adverse reactions to smallpox vaccination
- •Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day 1 vaccination or until the vaccination site heals completely: (a) children =< 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, (d) individuals with other acute, chronic, or exfoliative skin condition, or (e) immunocompromised or immunosuppressed persons (by disease or therapy)
- •Participants may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition of PROSTVAC
结局指标
主要结局
Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
时间窗: Baseline to up to 14 days after the last dose
change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
时间窗: Baseline to up to 14 days after the last dose
change (from pre to post-intervention) in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
次要结局
- Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies(Baseline to up to 14 days after the last dose)
- Change in Prostate-specific Antigen (PSA)(Baseline to 6 months post-intervention)
- Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies(Baseline to up to 14 days after the last dose)
- Tumor Grade Progression(Baseline to up to 14 days after the last dose)
- Change in PD-L1 Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies(Baseline to 6 months post-intervention)
- Change in PD-L1 Positive Cells in the Benign Portion of the Prostate Biopsies(Baseline to up to 14 days after the last dose)
- Proportion of Men With no Cancer in the Post-intervention Biopsy(Up to 14 days after the last dose)
- Change in International Prostate Symptom Score(Baseline to up to 6 months post-intervention)
- Size of Dominant MRI Lesion(Up to 14 days after the last dose)
- Change in Circulating 15-Mer PSA-specific T Cells(Baseline to up to 14 days after the last dose)
- Immunologic Effects on the Target Organ Using Multiplex Immunofluorescence(Up to 14 days after the last dose)
- Change in Tumor Extent(Baseline to up to 14 days after the last dose)
- Change in Soluble Antibodies to Tumor-associated Antigens(Baseline to up to 14 days after the last dose)
研究者
研究点 (14)
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