NCT00831844已完成2 期
A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 210
- 主要终点
- Disease Response
研究概览
简要总结
This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, 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.
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate to IMC-A12 (cixutumumab) administered in various strata of recurrent/refractory malignant solid tumors in childhood and young adulthood.
II. To further define and describe the toxicities of IMC-A12. III. To further characterize the pharmacokinetics of IMC-A12.
SECONDARY OBJECTIVES:
I. To examine the relationship between tumor expression of insulin-like growth factor (IGF)-I, IGF-II, and IGF-I receptor (IR) and response to IMC-A12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Months 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant solid tumor, including the following:
- •Osteosarcoma
- •Ewing sarcoma/peripheral primitive neuroectodermal tumor
- •Rhabdomyosarcoma
- •Neuroblastoma
- •Wilms tumor
- •Synovial sarcoma
- •Hepatoblastoma
- •Adrenocortical carcinoma
- •Retinoblastoma
- •No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
- •Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan
- •The following are not considered measurable disease:
- •Ascites, pleural effusions, or other malignant fluid collections
- •Bone marrow infiltration by tumor
- •Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)
- •Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy
- •No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months
- •Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2
- •Absolute neutrophil count (ANC) ≥ 1,000/mm³ (> 250/mm³ for patients with neuroblastoma)
- •Platelet count ≥ 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma) (transfusion independent)
- •Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed)
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows:
- •≤ 0.4 mg/dL (for patients 1 to 5 months of age)
- •≤ 0.5 mg/dL (for patients 6 to 11 months of age)
- •≤ 0.6 mg/dL (for patients 1 year of age)
- •≤ 0.8 mg/dL (for patients 2 to 5 years of age)
- •≤ 1 mg/dL (for patients 6 to 9 years of age)
- •≤ 1.2 mg/dL (for patients 10 to 12 years of age)
- •≤ 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- •≤ 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
- •Total bilirubin ≤ 1.5 times upper limit of normal for age
- •Alanine transaminase (ALT) ≤ 110 U/L
- •Serum albumin ≥ 2 g/dL
- •Blood glucose normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Able to comply with safety monitoring requirements of study
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
- •No uncontrolled infection
- •No known type I or II diabetes mellitus
- •Recovered from prior chemotherapy, immunotherapy, or radiotherapy
- •More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- •At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)
- •At least 6 weeks since prior monoclonal antibody therapy
- •At least 7 days since other prior antineoplastic biologic agents
- •No prior monoclonal antibody targeting the IGF-IR
- •No prior small molecule kinase inhibitors of IGF-IR
- •At least 2 weeks since prior local palliative (small port) radiotherapy
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease Response
时间窗: First six treatment cycles - 24 weeks
Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).
次要结局
未报告次要终点
研究者
研究点 (210)
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