A Phase II Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants Who Are Progression Free at One Year
研究概览
简要总结
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer.
PURPOSE: This phase II trial is studying how well the combination of a proven effective allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.
详细描述
OBJECTIVES:
Primary
- Determine the proportion of patients with androgen-independent prostate cancer who are progression-free at one year after treatment with DC-APCC.
Secondary
- Evaluate treatment toxicity.
- Evaluate time to prostate-cancer specific mortality.
- Evaluate progression-free survival.
- Evaluate time to PSA progression, and duration of PSA-based response.
- Evaluate quality of life of patients treated with this regimen.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonist, or another equivalent hormonal agent)
- •Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy)
- •Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer)
- •PSA 2.0-100.0 ng/mL
- •Serum testosterone < 50 ng/dL (unless undergoing antiandrogen monotherapy)
- •No concurrent evidence of radiological or new clinically palpable metastatic cancer
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy ≥ 12 weeks
- •WBC ≥ 3,500/µL
- •Platelet count ≥ 100,000/µL
- •Hemoglobin ≥ 10.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Fertile patients must use effective contraception
- •Willing to provide blood samples for research purposes
- •Able to complete questionnaire(s) alone or with assistance
- •Able to undergo leukapheresis
- •No known immunodeficiency
- •No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only
- •No concurrent serious illness
- •No known history of positive PPD skin test
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior therapy
- •More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents
- •Inhaled corticosteroids allowed
- •More than 1 month since prior and no concurrent estrogens and/or ketoconazole
- •More than 3 months since prior and no other concurrent investigational medicinal products
- •More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer
- •No prior prostate cancer vaccine
- •No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy
- •No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy
排除标准
- 未提供
研究组 & 干预措施
DC-APCC
Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
干预措施: allogeneic tumor cell vaccine (Biological)
DC-APCC
Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
干预措施: therapeutic autologous dendritic cells (Biological)
结局指标
主要结局
Number of Participants Who Are Progression Free at One Year
时间窗: One year
Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
次要结局
- Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire(Baseline and cycle 1)
- Progression Free Survival (PFS)(Up to 3 years)
- Number of Participants With Severe Adverse Events(Every cycle during treatment (up to 14 cycles))
- Time to Prostate-cancer Specific Mortality(Registration to Prostate-cancer specific mortality (Up to 3 years))
- Time to Prostate-specific Antigen (PSA) Progression(Registration to PSA progression (Up to 3 years))
- Duration of PSA-based Response(Up to 3 years)