Combination Immunotherapy for Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Evaluable Participants With Tumor Response
研究概览
简要总结
The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.
详细描述
This protocol describes a phase II study involving patients with stage IV adenocarcinoma of the lung. Treatment will consist of Cyclophosphamide (300 mg/m²) to be given IV on day 1 and day 57. On day 4 immunization with intradermal vaccine injections at 4 separate sites (bilateral upper arms and bilateral upper thighs will be repeated every 14 days times 2 followed by every 28 days times 3 (day 4, 18, 32, 60, 88, and 116). Decavac (tetanus shot) 0.5 cc intramuscular (IM) will be given after the first vaccine. ATRA (150 mg/m2/day) oral three times daily (TID) dosing administered after the first and fourth vaccines (day 5-7 & day 61-63). Those patients achieving stable disease (SD), partial response (PR), or complete response (CR) at restaging after the initial 6 vaccines will receive additional vaccines every 3 months until disease progression. The vaccine will consist of GM.CD40L bystander cells admixed with an equivalent number of the 2 allogeneic tumor cell lines. There will be a +/- 7 day window for all study related exams, tests, and procedures.
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 metastatic adenocarcinoma of the lung
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- •No radiation therapy within 2 weeks of first vaccine administration
- •No chemotherapy within 4 weeks of first vaccine administration
- •No steroid therapy within 4 weeks of first vaccine administration
- •Patient's written informed consent
- •Adequate organ function (measured within a week of beginning treatment)
- •Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion.
- •Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter greater than or equal 20mm. With spiral computer tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one dimension.
- •Patient's must have received, and completed first line chemotherapy.
排除标准
- •Symptomatic brain metastasis
- •Any acute medical problems requiring active intervention
- •Current corticosteroid (other than replacement doses in patients who are hypoadrenal) or other immunosuppressive therapy
- •Any other pre-existing immunodeficiency condition (including known HIV infection)
- •Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4
研究组 & 干预措施
Combination Immunotherapy
Vaccine + Cytoxan + ATRA as outlined in Detailed Description
干预措施: Vaccine Treatment (Biological)
Combination Immunotherapy
Vaccine + Cytoxan + ATRA as outlined in Detailed Description
干预措施: Cyclophosphamide (Drug)
Combination Immunotherapy
Vaccine + Cytoxan + ATRA as outlined in Detailed Description
干预措施: All-trans retinoic acid (ATRA) (Drug)
结局指标
主要结局
Number of Evaluable Participants With Tumor Response
时间窗: 3 years
Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.
次要结局
- Median Time to Progression (TTP)(3 years)
- Median Overall Survival (OS)(3 years)
- Number of Participants With Serious Adverse Events (SAEs)(3 years)