NCT00074295终止2 期
Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.
详细描述
OBJECTIVES:
- Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine.
- Determine the response rate (confirmed and unconfirmed and complete and partial) in patients treated with this vaccine.
- Determine the frequency and severity of toxic effects of this vaccine in these patients.
- Determine the functional status of patients treated with this vaccine.
- Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic cytokine responses) with clinical outcome in patients treated with this vaccine.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma (BAC) (yes vs no) and pattern of BAC (diffuse vs nodular).
After successful vaccine manufacturing from tumor tissue procured, patients receive GVAX lung cancer vaccine intradermally (ID) (6-7 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 9, 13, and 21.
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis* of 1 of the following by radiological features and clinical presentation:
- •Bronchoalveolar carcinoma (BAC)
- •Diffuse or ground glass appearance
- •Adenocarcinoma with bronchoalveolar features
- •BAC with focal invasion NOTE: *Histological confirmation (excluding fine needle aspiration or bronchial brushings or washings) is required after the tumor tissue has been procured and the vaccine has been produced
- •Selected stage IIIB (due to malignant pleural effusion) OR stage IV disease
- •Measurable or nonmeasurable disease (e.g., diffuse infiltrative process) by CT scan of the chest both before and after tumor tissue procurement for vaccine
- •Not a candidate for curative resection
- •Tumor accessible for tissue procurement via thoracentesis or a surgical procedure
- •If a pleural effusion is the source of tumor tissue, at least 600 mL of fluid must be available for vaccine manufacture
- •Resection of brain metastases may be used for vaccine processing
- •Surgery must be done after study entry
- •Asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastases allowed provided the patient is neurologically stable
- •No active or impending spinal cord compression or evidence of pericardial tamponade
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •CD4 count greater than 200/mm^3
- •No bleeding disorder
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
- •SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
- •Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases are present)
- •Not specified
- •Cardiovascular
- •See Disease Characteristics
- •Patients requiring surgery for tumor tissue procurement must meet the following criteria:
- •Pulmonary artery systolic pressure < 40 mm Hg by echocardiogram*
- •LVEF > 40%
- •No symptomatic congestive heart failure
- •No thrombolic disorder
- •No unstable angina pectoris
- •No cardiac arrhythmia NOTE: *Not needed if patient has no tricuspid regurgitation
- •No pulmonary hypertension
- •No significant baseline hypoxia (i.e., O_2 saturation less than 90% OR requires greater than 2 L/min of supplemental O_2 via nasal cannula) by an oxygen saturation test
- •No postobstructive pneumonia
- •Patients requiring thoracoscopic surgery or thoracotomy for tumor tissue procurement must meet the following criteria:
- •Alveolar partial pressure of CO_2 < 45 mm Hg
- •Predicted postresection FEV_1 ≥ 1.0 L
- •DLCO > 50% of predicted
- •Immunologic
- •No active immune or autoimmune disease
- •No systemic lupus erythematosus
- •No sarcoiditis
- •No rheumatoid arthritis
- 另有 41 项未显示
排除标准
- 未提供
研究组 & 干预措施
treatment
Experimental
GVAX lung cancer vaccine
干预措施: GVAX lung cancer vaccine (Biological)
结局指标
主要结局
Response rate
Functional status
Toxicity
Progression-free and overall survival
Correlation of systemic biologic activity with clinical outcome
次要结局
未报告次要终点
研究者
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