NCT00090896已完成1 期
A Phase I, Open Label, Study To Evaluate The Safety And Immune Function Effects Of CP-675,206 In Combination With MART-1 Peptide-Pulsed Dendritic Cells In Patients With Advanced Melanoma
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
- 2
- 主要终点
- Maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
研究概览
简要总结
RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines may make the body build an immune response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206) administered with autologous dendritic cells pulsed with MART-1 antigen in patients with unresectable stage III or stage IV melanoma.
- Determine the biological activity and immune effects of this regimen in these patients.
Secondary
- Correlate CTLA4 genotype with safety of this regimen and/or immune response in these patients.
- Determine, preliminarily, the efficacy of this regimen, in terms of clinical benefit rate, 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cutaneous or mucosal melanoma, meeting criteria for 1 of the following:
- •Unresectable stage III disease (locally relapsed unresectable, in-transit lesions, or unresectable draining nodes)
- •Stage IV disease, metastatic to 1 of the following sites:
- •Skin, subcutaneous tissues, or distant lymph nodes
- •Other visceral sites with lactic dehydrogenase ≤ 2 times upper limit of normal (unless due to liver stasis)
- •De novo metastatic disease allowed provided patient refused any standard or approved stage-appropriate therapy for melanoma
- •Measurable disease
- •HLA-A2.1 positive (HLA-A*0201 by molecular subtyping)
- •MART-1-expressing tumor by reverse transcription polymerase chain reaction or immunohistochemistry
- •No symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks
- •Age 18 and over
- •Performance status ECOG 0-1 OR
- •Karnofsky 70-100%
- •HIV negative
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study participation
- •More than 30 days since prior immunotherapy for metastatic, relapsed, or primary melanoma
- •More than 30 days since prior chemotherapy for metastatic, relapsed, or primary melanoma
- •More than 4 weeks since prior corticosteroids
- •More than 30 days since prior radiotherapy for metastatic, relapsed, or primary melanoma
- •More than 30 days since prior surgery for metastatic, relapsed, or primary melanoma.
- •More than 30 days since other prior therapy for metastatic, relapsed, or primary melanoma
- •More than 14 days since prior anti-infective therapy
- •More than 4 weeks since prior immune suppressive therapy (e.g., cyclosporine)
排除标准
- •chronic hepatitis B or C
- •inflammatory bowel disease
- •celiac disease
- •history of chronic colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding
- •active chronic inflammatory or autoimmune disease, including any of the following:
- •Psoriasis
- •Rheumatoid arthritis
- •Multiple sclerosis
- •Hashimoto's thyroiditis
- •Addison's disease
- •Graves' disease
- •Systemic lupus erythematosus
- •active infection OR fever over 100° F within the past 3 days
- •allergy to study drugs
- •symptomatic seizures
- •other medical problem that would preclude study participation
- •prior melanoma immunotherapy containing MART-1 antigen
- •prior anti-T-cell therapy
- •prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CP-675,206)
- •organ allografts requiring long-term immune suppressive therapy
结局指标
主要结局
Maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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