A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- PSA response
研究概览
简要总结
Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells
详细描述
OBJECTIVES:
I. Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate.
II. Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients.
III. Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients.
IV. Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following:
- •Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL
- •Bone scan positive and PSA at least 10 ng/mL
- •Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL
- •Prior radiotherapy and PSA at least 10 ng/mL
- •Prior cryosurgery and PSA at least 10 ng/mL
- •PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079
- •No symptomatic metastatic disease (no bony pain)
- •Complete HLA typing required
- •Performance status - ECOG 0 or 1
- •WBC greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •SGPT less than 4 times upper limit of normal
- •Creatinine less than 4.0 mg/dL
- •No altered immune function such as eczema
- •No autoimmune diseases such as the following:
- •Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- •Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma
- •Myasthenia gravis
- •Goodpasture's syndrome
- •Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
- •HIV negative
- •No allergy or untoward reaction to prior vaccinia (smallpox) vaccination
- •No hypersensitivity to eggs
- •No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster)
- •No other concurrent serious illness
- •No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days
- •Fertile patients must use effective contraception
- •No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination:
- •Children under age 5
- •Pregnant or nursing women
- •Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders
- •Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- •Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection
- •See Disease Characteristics
- •See Endocrine therapy
- •Prior vaccinia (smallpox) immunization required
- •No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer
- •No prior chemotherapy for metastatic disease
- •No concurrent anticancer chemotherapy
- •No prior hormonal therapy for metastatic disease
- •Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed
- •Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B)
- •No concurrent hormonal therapy or steroids
- •See Disease Characteristics
- •See Endocrine therapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •See Endocrine therapy
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive the same vaccines as in arm I but in reverse order.
干预措施: recombinant vaccinia prostate-specific antigen vaccine (Biological)
Arm I
Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.
干预措施: recombinant fowlpox-prostate specific antigen vaccine (Biological)
Arm I
Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive the same vaccines as in arm I but in reverse order.
干预措施: recombinant fowlpox-prostate specific antigen vaccine (Biological)
Arm II
Patients receive the same vaccines as in arm I but in reverse order.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.
干预措施: recombinant vaccinia prostate-specific antigen vaccine (Biological)
结局指标
主要结局
PSA response
时间窗: Up to 3 months after the final vaccine dose
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.
次要结局
未报告次要终点