NCT00503568已完成1 期
Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells.
PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.
详细描述
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.
Secondary Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 NSCLC (squamous, adeno-, large cell anaplastic, bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural effusion, stage IV, or recurrent disease.
- •At least one site of bi-dimensionally measurable disease.
- •Metastasis if present and treated must be stable by CT scan or MRI for at least 8 weeks.
- •Patient must have received and failed at least one line of chemotherapy.
- •Age >= 18 years.
- •ECOG performance status 0-
- •Life expectancy >= 3 months.
- •Laboratory parameters:
- •Hemoglobin levels >= 10.0 (transfusions allowed if necessary).
- •ANC >= 1,
- •Platelets >= 100k.
- •Creatinine clearance >= 50 ml/min.
- •Total and direct bilirubin: < 2.5 X upper institution limit for normal.
- •Liver function tests: AST, ALT, and AlkP < 2.5 X upper institution limit for normal.
- •Signed informed consent.
- •Autopsy consent - although not a requirement for study entry, patients who consent to participate in study will be made aware of the critical importance of a post-mortem examination in the event of the patient's death after receiving therapy with this experimental vaccine. Therefore, pre-treatment written agreement to autopsy will be sought from the patient, or verbal agreement to autopsy will be sought in the presence of the next of kin or other family members.
排除标准
- •Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. Patients with history of these conditions who are stable taking cardiac medications will also be excluded.
- •Pregnant or lactating women (negative test for pregnancy is required of women of childbearing potential).
- •Known HIV infection.
- •Uncontrolled or untreated brain or spinal cord metastases.
- •Active infection.
- •Concomitant steroid or other immunosuppressive therapy.
- •Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
- •Alcohol or chemical abuse.
- •Meningeal carcinomatosis.
- •Chemotherapy, radiation therapy, or other anti-tumor therapy during the last four weeks.
- •Prior biologic response modifier therapy.
- •Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
- •Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, glomerulonephritis.
- •Compromised lung function:
- •FeV1 < 30% of the predicted value, or
- •DLCO < 30% of the predicted value, or
- •PCO2 > 45 mmHg.
- •Any patient enrolled on study whose respiratory symptoms have experienced marked deterioration not related to a known cause, such as pneumonia, congestive heart failure, or pulmonary embolism, will have a repeat PFT evaluation, and if the above parameter values for FeV1, DLCO, or PCO2 are seen, will be excluded from further treatment.
研究组 & 干预措施
DS-1: gp96-ig Dose Schedule 1
Experimental
Dose Schedule 1 (DS-1): Ad100-gp96Ig-HLA A1 Vaccine 4x10^7 cells bi-weekly, maximum 9 vaccines/patient;
干预措施: Ad100-gp96Ig-HLA A1 (Biological)
DS-2: gp96-ig Dose Schedule 3
Experimental
Dose Schedule 2 (DS-2): Ad100-gp96Ig-HLA A1 Vaccine 2X10^7 cells weekly, maximum 18 vaccines/patient;
干预措施: Ad100-gp96Ig-HLA A1 (Biological)
DS-3: gp96-ig Dose Schedule 3
Experimental
Dose Schedule 3 (DS-3): Ad100-gp96Ig-HLA A1 Vaccine 1x10^7 cells twice weekly, maximum 36 vaccines/patient
干预措施: Ad100-gp96Ig-HLA A1 (Biological)
结局指标
主要结局
Safety
时间窗: 6, 12, 18, 24, and 36 months post enrollment
次要结局
- Immunologic response: CD8, CD4 and NK response(Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19)
研究者
研究点 (1)
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