NCT00514072Unknown2 期
A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Time to PSA progression
研究概览
简要总结
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in patients with androgen-dependent stage D0 prostate cancer.
Secondary
- To evaluate all toxicities related to ONY-P1 vaccine.
- To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo.
- To evaluate PSA kinetics (doubling time/velocity) of treatment.
- To evaluate time to testosterone recovery following limited androgen ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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:
- •Histopathological documentation of prostate cancer
- •If no pathologic specimen is available, patients may enroll on study with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease
- •Biochemical progression, as defined by the following:
- •A rise in PSA of ≥ 2 ng/mL above the nadir (for patients previously treated with definitive radiotherapy or cryotherapy)
- •Two consecutive rises in PSA > 0.3 ng/mL (for patients previously treated with radical prostatectomy)
- •PSA ≤ 20 ng/mL
- •Testosterone ≥ lower limit of normal
- •Negative CT scan and bone scan for metastatic prostate cancer
- •No clinically active brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 0-1
- •Life expectancy ≥ 6 months
- •Granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin ≤ 1.5 mg/dL OR total bilirubin ≤ 3.0 mg/dL (in patients with Gilbert's syndrome)
- •AST and ALT ≤ 2.5 times upper limit of normal
- •No other active malignancies within the past 60 months (with the exception of nonmelanoma skin cancer or carcinoma in situ of the bladder)
- •No life-threatening illnesses
- •No immunocompromised status due to any of the following:
- •HIV positivity
- •Active autoimmune diseases, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjögren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease
- •Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function, including CNS, heart, lungs, kidneys, skin, or gastrointestinal tract, will be allowed
- •Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs
- •No other serious medical illness that would interfere with the patient's ability to carry out the treatment program
- •No documented contraindication (allergy or severe reaction to BCG)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior therapy, including surgery and radiotherapy (no toxicity ≥ grade 2)
- •No prior chemotherapy
- •No concurrent topical steroids (including steroid eye drops) or systemic steroids
- •Nasal or inhaled steroid use is permitted
- •No concurrent medications used for urinary symptoms, including 5-alpha reductase inhibitors (finasteride and dutasteride)
- •No concurrent alternative medications known to alter PSA (e.g., phytoestrogens or saw palmetto)
- •No other concurrent hormonal therapy
- •No other concurrent anticancer treatment, including chemotherapy, systemic glucocorticoids, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: prostate cancer vaccine ONY-P1 (Biological)
Arm II
Placebo Comparator
Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
Arm I
Experimental
Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: BCG vaccine (Biological)
结局指标
主要结局
Time to PSA progression
次要结局
- Immunologic response as assessed by ELISPOT assay
- Toxicity
- PSA kinetics (doubling time/velocity) of treatment
- Time to testosterone recovery
研究者
研究点 (1)
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