NCT00831545已完成2 期
Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-small Cell Lung Cancer.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Best response related to brain metastases observed during the study period.
研究概览
简要总结
The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if >=10 patients will respond. If <2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
- •Brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
- •Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
- •Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
- •Age <=70 years.
- •Performance status 0-2 (ECOG-WHO scale).
- •Blood leukocytes >=3.5 x 10^9/L and platelets >=100 x 10^9/L.
- •Bilirubin <=25 M/L.
- •Seric transaminases <=2 x upper limit of normal values.
- •Creatinine <=150 M/L, creatinine clearance >=60 mL/min.
- •Signed written informed consent.
排除标准
- •Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
- •Previous whole brain irradiation.
- •Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
- •Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
- •Pregnant or nursing women.
- •Acute infection requiring intravenous antibiotics.
- •Severe vomiting or medical condition which could interfere with oral medication intake.
- •Anticonvulsant chronic therapy.
研究组 & 干预措施
Subjects with melanoma
Experimental
干预措施: Temozolomide (Drug)
Subjects with breast cancer
Experimental
干预措施: Temozolomide (Drug)
Subjects with non-small cell lung cancer
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Best response related to brain metastases observed during the study period.
时间窗: After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.
次要结局
- Adverse events according to NCI CTC grading system of toxicity.(Throughout the study.)
- Progression-free survival, brain progression-free survival, and overall survival.(After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.)
研究者
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