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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

2013年2月8日 更新者:National Cancer Institute (NCI)

A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.

研究概览

详细说明

OBJECTIVES:

I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate.

II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity.

III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity.

IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone.

OUTLINE: This is an open label, dose escalation study.

Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

Patients are followed monthly for 6 months.

研究类型

介入性

注册 (实际的)

46

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana-Farber Cancer Institute
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease based on any of the following:

    • Lymph node positive and PSA at least 10 ng/mL
    • Bone scan positive and PSA at least 10 ng/mL
    • PSA at least 2 ng/mL and rising following radical prostatectomy
    • PSA at least 10 ng/mL following radiotherapy
  • No symptomatic metastatic disease (bony pain)

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0 or 1
  • WBC greater than 2,000/mm3
  • Platelet count greater than 100,000/mm3
  • Bilirubin less than 2.0 mg/dL
  • AST less than 4 times normal
  • Creatinine less than 2.0 mg/dL
  • Must be type HLA-A2 Prior vaccinia (smallpox) exposure required
  • At least normal delayed type hypersensitivity to mumps and Candida
  • At least normal CD4:CD8 ratio (greater than 1)
  • At least normal lymphocyte proliferation testing (to Con A)
  • At least normal immunoglobulin levels
  • No evidence of altered immune responsiveness or autoimmune syndromes (e.g., scleroderma, systemic lupus erythematosus)
  • No HIV antibody No prior splenectomy
  • No known allergy to eggs
  • No active extensive skin disorders (e.g, psoriasis, burns, impetigo, disseminated zoster)
  • No other serious intercurrent illness
  • No active infections unless cleared and at least 3 days since antibiotic therapy
  • No close contact for 2 weeks after each vaccination with the following people:

    • Children less than 3 years old
    • Pregnant women
    • Individuals with eczema or skin conditions listed above
    • Immunosuppressed individuals

PRIOR CONCURRENT THERAPY:

  • No concurrent biologic therapy
  • No prior chemotherapy for metastatic disease
  • No prior hormone therapy for metastatic disease
  • Neoadjuvant hormone therapy prior to prostatectomy or radiotherapy allowed
  • No concurrent steroids or hormonal medications
  • Prior radiotherapy allowed
  • Prior surgery allowed

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm I
atients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Eder JP Jr, Kantoff PW, Bubley GJ, et al.: A phase I trial of recombinant prostate specific antigen expressing vaccinia virus vaccine, PROSTVAC (rV-PSA) in advanced prostate cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1692, 439, 1999.
  • Eder JP Jr, Kantoff PW, Bubley GJ, et al.: A phase I trial of recombinant vaccinia virus, PROSTVAC that expresses prostate specific antigen (rV-PSA) as a vaccine in men with advanced prostate cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1672, 434, 1998.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1996年12月1日

初级完成 (实际的)

2006年5月1日

研究注册日期

首次提交

1999年12月10日

首先提交符合 QC 标准的

2004年8月27日

首次发布 (估计)

2004年8月30日

研究记录更新

最后更新发布 (估计)

2013年2月11日

上次提交的符合 QC 标准的更新

2013年2月8日

最后验证

2006年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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