NCT00433446已完成2 期
A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 123
- 主要终点
- Confirmed Prostate-Specific Antigen (PSA) Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
详细描述
OBJECTIVES:
Primary
- Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody.
Secondary
- Assess overall survival and progression-free survival of these patients.
- Assess the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this regimen.
- Assess the qualitative and quantitative toxicities of 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
- •Metastatic disease (N1 and/or M1)
- •Disease unresponsive or refractory to androgen-deprivation therapy
- •Must have received only 1 prior chemotherapy regimen comprising a taxane OR mitoxantrone
- •Disease progression as defined by one or more of the following:
- •Progression of measurable disease
- •Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months ago and lesion progressed since radiotherapy
- •Progression of nonmeasurable disease
- •Prior radiotherapy within the past 2 months allowed, but disease is considered nonmeasurable
- •Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR within 6 months of last chemotherapy dose
- •Rising PSA defined as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1)
- •PSA ≥ 5 ng/mL
- •Surgical or medical castration required
- •Castration using luteinizing hormone-releasing hormone agonist (leuprolide acetate or goserelin) or antagonist (abarelix) should not be interrupted
- •No history of brain metastases OR currently treated or untreated brain metastases
- •Patients with clinical suspicion of brain metastases must have a brain CT scan or MRI negative for metastatic disease within the past 56 days
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-2
- •Fertile patients must use effective contraception
- •Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)
- •Platelet count ≥ 100,000/mm³ (transfusion independent)
- •Hemoglobin ≥ 9 g/dL (transfusion independent)
- •Creatinine clearance ≥ 40 mL/min
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) ≤ 2 times ULN
- •No uncontrolled intercurrent illnesses including, but not limited to, the following:
- •Diabetes mellitus
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •No psychiatric illness or social situation that would preclude study compliance
- •No known HIV positivity
- •No other prior malignancy except for the following:
- •Adequately treated basal cell or squamous cell skin cancer
- •Adequately treated stage I or II cancer in complete remission
- •Any other cancer from which the patient has been disease-free for 5 years
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 21 days since prior surgery and recovered
- •At least 28 days since prior chemotherapy and recovered
- •At least 28 days since prior flutamide or ketoconazole
- •At least 28 days since prior radiotherapy (to < 30% of the bone marrow only) and recovered
- •Prior samarium Sm 153 lexidronam pentasodium allowed
- •No prior strontium chloride Sr 89
- •At least 42 days since prior bicalutamide or nilutamide
- •More than 60 days since prior murine or chimeric proteins or human/murine monoclonal antibody
- •Concurrent bisphosphonate therapy allowed provided the following are true:
- •Therapy commenced at least 3 weeks ago
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
CNTO 328
Experimental
干预措施: CNTO 328 (Biological)
结局指标
主要结局
Confirmed Prostate-Specific Antigen (PSA) Response
时间窗: Assessed every 3 cycles (1 cycle = 14 days) until progression
PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.
次要结局
- Progression-free Survival (PFS)(Assessed every 3 cycles (1 cycle = 14 days) until progression)
- Overall Survival (OS)(0-3 yeas after registration)
- Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease(Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression)
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment)
研究者
研究点 (123)
Loading locations...
相似试验
撤回
2 期
S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney CancerKidney CancerNCT00311545SWOG Cancer Research Network
已完成
1 期
MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung CancerLung CancerNCT00869752NCIC Clinical Trials Group12
已完成
2 期
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced NeuroblastomaNeuroblastomaNCT00002560Memorial Sloan Kettering Cancer Center40
已完成
2 期
Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV MelanomaMelanoma (Skin)NCT00471887Jonsson Comprehensive Cancer Center32
已完成
3 期
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's DiseaseCrohn's DiseaseNCT00004941FDA Office of Orphan Products Development94