A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells.
详细描述
OBJECTIVES:
I. Determine the efficacy of APC8015 (Provenge) and bevacizumab, in terms of decline in prostate-specific antigen (PSA) value and effect on PSA doubling time, in patients with progressive prostate cancer.
II. Determine any immune response in patients treated with this regimen. III. Determine the safety of this regimen in these patients.
OUTLINE:
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Any T, any N, M0
- •Received prior therapy comprising one of the following regimens for primary prostate cancer:
- •External beam radiotherapy
- •Brachytherapy with or without pelvic external beam radiotherapy
- •Cryosurgery
- •Radical prostatectomy with or without adjuvant or salvage radiotherapy
- •Adjuvant or salvage radiotherapy after radical prostatectomy is allowed provided the following criteria is met:
- •PSA was never greater than 6.0 ng/mL
- •At least 3 months since androgen deprivation
- •Elevated PSA (0.4-6.0 ng/mL) that has increased on 2 measurements taken at least 2 weeks apart
- •No history of or radiological evidence of current CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 12 months
- •Hematopoietic:
- •WBC greater than 2,500/mm^3
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •No prior bleeding disorder
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST no greater than 2 times ULN
- •Hepatitis B and C negative
- •Creatinine no greater than 2 times ULN
- •BUN no greater than 2 times ULN
- •Cardiovascular:
- •No clinically significant cardiovascular disease
- •No New York Heart Association grade II-IV heart disease (symptomatic congestive heart failure)
- •No unstable angina pectoris
- •No serious cardiac arrhythmia requiring medication
- •No uncontrolled hypertension
- •No prior myocardial infarction
- •No grade II or greater peripheral vascular disease within the past year
- •No prior deep vein thrombosis
- •Fertile patients must use effective contraception
- •HIV and HTLV I and II negative
- •No other uncontrolled illness, underlying medical condition, psychiatric illness, or social situation that would preclude study participation
- •No ongoing or active infection
- •No active autoimmune disease requiring treatment
- •No significant traumatic injury within the past 4 weeks
- •No serious nonhealing wound, ulcer, or bone fracture
- •No other "currently active" malignancy except nonmelanoma skin cancer
- •Not "currently active" if considered by physician as having less than 30% risk of relapse after completion of therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy
- •No prior anti-vascular endothelial growth factor therapy
- •Chemotherapy:
- 另有 14 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: in vitro-treated peripheral blood stem cell transplantation (Procedure)
Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: prostatic acid phosphatase-sargramostim fusion protein (Biological)
Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: therapeutic autologous dendritic cells (Biological)
Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: sipuleucel-T (Biological)
Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)