CTRI/2010/091/001348进行中（未招募）2 期
PHASE II CLINICAL TRIAL OF IMMUNOTHERAPY WITH AN ALLOGENEIC B7.1/HLA-A1 TRANSFECTED TUMOR CELL VACCINE (PT 107) IN PATIENTS WITH STAGES IIIB/IV NON-SMALL CELL LUNG CANCER THAT HAVE COMPLETED FIRST LINE CHEMOTHERAPY
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Determine whether patients with advanced or metastatic non-small cell lung cancer (stages IIIB/IV) who have failed previous platinum-based chemotherapy (with or without radiation) have an increase in overall survival as a result of vaccination with PT 107.
研究概览
简要总结
This study is a randomized, double blind, placebo controlled multi-centric trial to determine the safety and efficacy of the PT 107 vaccine in patients with non-small cell lung carcinoma (with stages IIIB & IV). Study will be conducted at 9 centers in India. The primary outcome measures will be to determine the overall survival rate in the patients who have failed previous platinum based chemotherapy. The secondary outcome measures will be to check the safety profile of PT 107 and time to disease progression in patients immunized with PT 107 vaccine as compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •Patients with documented stage IIIB or IV advanced or metastatic NSCLC who have completed 4-6 cycles of platinum based chemotherapy, with or without radiation, and have either stable disease or have experienced disease progression (additional prior adjuvant chemotherapy is permitted).
- •ECOG performance status 0-2.
- •Presence of at least one measurable lesion according to RECIST criteria.
- •Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.
- •Pulmonary Function RequirementsAll patients will undergo evaluation of pulmonary function prior to enrollment.
- •Patients should have a FeV1 more than 30% of the predicted value and/or DLCO more than 30% of the predicted value with a PCO2 < 45mm.
- •Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, CHF or PE) will have request PFT evaluation and if the above parameters are not fulfilled will be excluded from the protocol.
- •Age > or = 18 years.
- •Signed informed consent.
- •ANC > or =1000/mm3; PLT> or = 80,000/mm3.
- •Hemoglobin > or = 10 g/dL.
排除标准
- •Small cell carcinoma of the lung.
- •Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
- •Other active malignancies present within the past three years, except for basal and / or squamous cell carcinoma(s) or in situ cervical cancer.
- •Concomitant steroid or other immunosuppressive therapy.
- •Active infection, or less than 7 days since therapy for acute infections.
- •Pericardial effusion.
- •Currently receiving chemotherapy for another condition (such as arthritis).
- •Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
- •Pregnant or lactating women (negative test for pregnancy required of women of child bearing potential).
- •Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
- •Known HIV infection.
- •Untreated or uncontrolled brain metastasis.
- •ASL or ALT > or = 2.5 times the upper limit of normal (ULN).
- •Alkaline Phosphatase > or = 5 times ULN.
结局指标
主要结局
Determine whether patients with advanced or metastatic non-small cell lung cancer (stages IIIB/IV) who have failed previous platinum-based chemotherapy (with or without radiation) have an increase in overall survival as a result of vaccination with PT 107.
时间窗: From the date of randomization to the recorded date of death
次要结局
- 1. Safety profile of the PT 107. 2. Time to disease progression in patients immunized with PT 107 vaccine as compared to placebo.(1. Monitored for safety throughout the study. 2. 1st assessment at 13th week and follow-up assessment on 18th week)
研究者
研究点 (7)
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