NCT00101257已完成1 期
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and toxicity
研究概览
简要总结
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer.
- Determine the duration of in vivo persistence of this drug in these patients.
Secondary
- Determine the antitumor effect of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:
- •Progressive* or persistent* disease during or after primary chemotherapy
- •Recurrent disease < 6 months after completion of primary therapy that had resulted in a complete response
- •Persistent* or recurrent disease after second-line or additional therapies NOTE: *Progression or persistence can be based on serological (CA 125 > 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings
- •Tumor expressing NY-ESO-1 determined by IHC or RT-PCR
- •HLA type expressing DPB*0401, DPB1*0201, DRB1*07
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •More than 16 weeks
- •Hematopoietic
- •Not specified
- •Not specified
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No congestive heart failure*
- •No clinically significant hypotension*
- •No symptoms of coronary artery disease*
- •No cardiac arrhythmias on EKG requiring drug therapy*
- •No history of cardiovascular disease*
- •No other significant cardiovascular abnormalities* NOTE: *Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation
- •FEV_1 ≥ 60% of predicted*
- •DLCO ≥ 55%* NOTE: *Patients with clinically significant pulmonary dysfunction only
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No active infection
- •No oral temperature > 38.2°C within the past 72 hours
- •No systemic infection requiring chronic maintenance or suppressive therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior standard or experimental chemotherapy
- •Endocrine therapy
- •No concurrent systemic corticosteroids except for treatment-related toxicity
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior immunosuppressive therapy
- •More than 3 weeks since prior investigational drugs and recovered
- •No other concurrent investigational agents
- •No concurrent pentoxifylline
排除标准
- 未提供
结局指标
主要结局
Safety and toxicity
Duration of in vivo persistence
Antitumor effects
次要结局
未报告次要终点
研究者
研究点 (1)
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