一步错步步错 发表于 2012-5-4 22:46
什么叫“控制中的脑转和骨转”呢？能帮忙解释下吗？
下面就是入组的要求，和脑转骨转相关的主要有两句话：
Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
病人脑转（单个或多个）治疗后病灶稳定大于2个月的可以入组。
Painful bone metastases, or bone metastases that require immediate therapy.
骨转疼痛的，或者骨转需要立即治疗的不能入组。
另外提到了要经过铂类药物化疗6轮以后的才能入组。这可能只是试验设计的需要，和药物适用范围没有关系。
Criteria
Inclusion Criteria:
•Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
•Stage IIIA (T3N2 only) or
•Stage IIIB or
•Stage IV.
•Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
•Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
•Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
•Signed informed consent.
•Not less than 18 years and not more than 75 years old.
•Estimated life expectancy of at least 12 weeks.
• erformance status (ECOG) ≤ 2.
•Absolute neutrophil count ≥ 1,500/mm3.
•Hemoglobin ≥ 9 g/dL.
•latelet count ≥ 100,000/mm3.
•Albumin levels ≥ 2.5 g/dL.
•Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
•Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
•Creatinine ≤ 1.5 × ULN.
•Alkaline phosphatase ≤ 5 × ULN.
Exclusion Criteria:
•Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
•rior splenectomy.
•Any surgery involving general anesthesia < 4 weeks prior to study registration.
•Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
•Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
•Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
•ainful bone metastases, or bone metastases that require immediate therapy.
•Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
•Known allergies to eggs or soy.
•Significant weight loss (≥ 10% body weight in preceding 6 weeks).
•Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
•Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
•NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
•rior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
•History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
•regnant or nursing women, or refusal to practice contraception if of reproductive potential.
•Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
•Known active Epstein-Barr infection within ≤ 60 days of study registration.
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