NCT00516217已完成2 期
A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 56
- 主要终点
- Overall Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the response rate (complete and overall response) in patients with relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
Secondary
- To assess the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory HL.
- To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL.
- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed classical Hodgkin lymphoma (HL):
- •Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies
- •Fine needle aspirates are not acceptable
- •Recurrent or refractory disease after at least two prior standard chemotherapy regimens
- •Nodular lymphocyte predominant HL allowed
- •Measurable disease must be present on either physical examination or imaging studies
- •Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm
- •Evaluable or non-measurable disease alone is not acceptable including any of the following:
- •Bone lesions (lesions, if present, should be noted)
- •Bone marrow involvement (if present, this should be noted)
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Ineligible for a stem cell transplantation
- •Patients eligible for CALGB-50502 should not be considered for this study
- •No known CNS involvement
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 500/μL
- •Platelet count ≥ 50,000/μL
- •Creatinine ≤ 2.0 mg/dL
- •Total bilirubin ≤ 2.0 mg/dL (no history of Gilbert Disease)
- •AST ≤ 2.5 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study
- •No known HIV infection
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered to ≤ grade 1 from all toxicities related to prior treatments
- •At least 4 weeks since prior chemotherapy, radiotherapy, or biologic anticancer therapy
- •Prior autologous and/or allogeneic stem cell transplantation allowed
- •No prior anti-CD80 antibody
- •No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
- •The use of dexamethasone and other steroidal antiemetics is prohibited unless to treat acute grade 3 or 4 monoclonal antibody-associated infusion reactions not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine
- •Dexamethasone is also allowed for re-treatment after an infusion reaction
排除标准
- 未提供
研究组 & 干预措施
Galaximab
Experimental
Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
干预措施: galiximab (Biological)
结局指标
主要结局
Overall Response
时间窗: Duration of treatment (up to 10 years)
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions.
次要结局
- 12 Month Overall Survival Rate(12 months)
- 6 Month Progression Free Survival Rate(6 months)
研究者
研究点 (56)
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