NCT00054405终止1 期
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 28
- 主要终点
- Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
研究概览
简要总结
Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.
详细描述
OBJECTIVES:
I. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma.
II. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients.
III. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients.
IV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neuroblastoma
- •Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
- •Persistent and/or refractory disease, with at least 1 of the following:
- •Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
- •Progressive disease after nonmyeloablative or myeloablative therapy
- •Recurrent disease, evidenced by any of the following:
- •Biopsy-proven recurrent soft tissue disease
- •Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
- •Histologically confirmed bone marrow disease
- •Progressive or stable disease after at least 1 prior standard salvage regime
- •No clinically significant pleural effusion
- •Life expectancy >= 12 weeks
- •Hepatitis A antibody negative
- •Hepatitis B surface antigen negative
- •Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
- •Hepatitis C virus negative
- •No history of congenital or acquired coagulation disorder
- •Cardiac function normal by ECG
- •No dyspnea at rest
- •No exercise intolerance
- •Oxygen saturation at least 94% by pulse oximetry
- •DLCO greater than 60% of predicted
- •FEV1 greater than 70% of predicted
- •Negative pregnancy test
- •Skull-based bony lesions without space-occupying intracranial extension are allowed
- •No prior or concurrent intracranial metastatic disease to the brain parenchyma
- •Not pregnant or nursing
- •Fertile patients must use effective barrier contraception during and for at least 2 months after study
- •No prior hematologic malignancy (including leukemia or lymphoma)
- •No history of malignant hyperthermia
- •No prior or concurrent autoimmune disease
- •No positive direct Coombs testing
- •No history of ongoing or intermittent bowel obstruction
- •No active infection or other significant systemic illness
- •More than 2 weeks since prior fenretinide
- •More than 2 weeks since prior 13-cis-retinoic acid
- •More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- •More than 2 weeks since prior interferons or interleukins
- •More than 2 weeks since prior cytokine-fusion proteins
- •More than 2 weeks since prior IV immunoglobulin (IVIG)
- •No prior interleukin-12
- •No concurrent cytokines
- •No concurrent fenretinide
- •No concurrent 13-cis-retinoic acid
- •No other concurrent immunomodulators, including:
- •G-CSF and GM-CSF
- •Interferons
- •Other interleukins
- •More than 4 weeks since prior chemotherapy
- •No other unstable medical condition or critical illness that would preclude study participation
- 另有 23 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
时间窗: 28 days
次要结局
- Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)(Up to 3 weeks)
研究者
研究点 (28)
Loading locations...
相似试验
终止
1 期
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis FungoidesRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Mycosis Fungoides/Sezary SyndromeStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Mycosis Fungoides/Sezary SyndromeStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Mycosis Fungoides/Sezary SyndromeStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Mycosis Fungoides/Sezary SyndromeNCT00052377National Cancer Institute (NCI)46
已完成
1 期
Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00005604National Cancer Institute (NCI)25
已完成
1 期
Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid TumorsRecurrent Breast CancerRecurrent Endometrial CarcinomaRecurrent Gastric CancerRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Small Cell Lung CancerMale Breast CancerNCT00028535National Cancer Institute (NCI)18
已完成
2 期
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant MelanomaRecurrent MelanomaStage IV MelanomaNCT00026143National Cancer Institute (NCI)60
已完成
1 期
Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced CancerChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol SpecificLymphomaLeukemiaNCT00003451National Cancer Institute (NCI)40