Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC# 732442, Previously 720801) in Patients Previously Vaccinated With GM-CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients With Acute Myelogenous Leukemia/ Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received a Prior Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
研究概览
简要总结
This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety of MDX-CTLA-4 in patients previously and not previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia or lung cancer cells.
II. To identify preliminary evidence of biologic activity and efficacy.
OUTLINE:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia, or non-small cell lung cancer cells; patients with acute myelogenous leukemia/myelodysplasia or non-small cell lung cancer who have not been vaccinated with an autologous, GM-CSF based vaccine
- •>= 4 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy)
- •Patients must have recovered from any acute toxicity associated with prior therapy
- •Measurable epithelial ovarian cancer, melanoma, AML/MDS, or non-small cell lung cancer
- •No standard curative treatment options
- •Not require immediate palliative therapy
- •Patients with epithelial ovarian cancer must have persistent or recurrent disease following primary surgery and primary chemotherapy
- •Patients with melanoma must be stage IV disease
- •Patients with AML/MDS, but without MDS, must be: a) in second relapse or b) first relapse with no option for bone marrow transplant or c) not a candidate for immunosuppressive chemotherapy due to age or comorbid disease
- •Patients with non-small cell lung cancer must be not curable by standard surgery, chemotherapy, and/or radiation
- •Life expectancy >= 12 weeks
- •ECOG performance status of 0, 1 or 2
- •Written informed consent
- •Due to the unknown effects of MDX-CTLA-4 on the fetus or nursing infant, pregnant or nursing women should not be included; women should be either: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing an intrauterine device, and/or spermicide and barrier, for contraception; during the study, use of oral contraception alone is not acceptable; women of childbearing potential must have a negative serum beta-HCG pregnancy test conducted during screening, and a negative urinary beta-HCG pregnancy test conducted within 24 hours prior to treatment; due to the unknown effects of MDX-CTLA-4 on the fetus, men should not father children during the study
- •WBC > 1,000 cells/mm^3 (except for AML/MDS patients)
- •Serum creatinine < 2 mg/dL
- •Platelets > 75,000 cells/mm^3 (except for AML/MDS patients)
- •AST and ALT < 2 x UNL
- •Total bilirubin < 2 x UNL
排除标准
- •Active infection
- •Autoimmune disease requiring immunosuppressive treatment
- •Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- •Any concurrent medical condition requiring the use of systemic steroids (use of inhaled or topical steroids is acceptable)
- •CNS metastases, unless previously treated and stable for at least three months
- •Patients who have received prior treatment with MDX-CTLA-4
研究组 & 干预措施
Treatment (ipilimumab)
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.
干预措施: ipilimumab (Biological)
结局指标
主要结局
Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
时间窗: Up to 6 years
次要结局
- Proportion of patients who mount a brisk immune response, graded as absent, non-brisk, and brisk as described by Mihm(Up to 2 months post-treatment)
- Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 6 years)