NCT00392171已完成2 期
The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
研究概览
简要总结
The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m^2).
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, greater than 18 years old.
- •Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).
- •Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide, with radiological evidence of progression.
- •GBM treated with concurrent chemoradiation with temozolomide according to the EORTC/NCIC (European Organization for Research & Treatment of Cancer/National Cancer Institute of Canada) protocol.
- •Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]).
- •Patients must be enrolled within 2 weeks of last radiological confirmation of progression, except for patients undergoing surgical resection.
- •Patients undergoing surgical resection for recurrent disease must be enrolled within 2 weeks of the post-surgical scan.
- •Patients with no residual disease after surgery are allowed.
- •Steroids dose should have been stabilized during the last 2 weeks prior to enrollment.
- •Use of medically approved contraception in fertile males and females.
- •Women of childbearing potential must have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG [beta human chorionic gonadotropin]) within 24 hours of inclusion in the study.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or
- •Signed informed consent form.
排除标准
- •GBM progression during the first 2 months of adjuvant temozolomide (5/28).
- •AA progression during the first 2 months of standard temozolomide therapy (5/28).
- •Chemotherapy for the malignant glioma other than temozolomide.
- •More than one prior course of chemotherapy with temozolomide.
- •Patient evolving from anaplastic glioma to GBM following primary therapy.
- •Patient older than 70 years or who received no conventional chemoradiation regimen.
- •Patient who received radiotherapy for recurrent disease.
- •Patient with metastatic disease.
- •Known human immunodeficiency virus (HIV) infection.
- •History of non-compliance to other therapies.
- •Inadequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):
- •Absolute neutrophil count <=1.5 ×10^9/L;
- •Platelets <=100 ×10^9/L;
- •Hemoglobin <90 g/L;
- •Serum creatinine >=1.5 times upper limit of laboratory normal (ULN);
- •Total serum bilirubin >=1.5 times ULN;
- •ASAT (AST [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >2.0 times ULN;
- •Alkaline phosphatase of >2.5 times ULN.
- •Known chronic hepatitis B or hepatitis C infection.
- •Any other serious medical condition, according to the medical judgment of the physician prior to inclusion in the study.
- •Any medical condition that could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
- •Other malignancies during the previous 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.
- •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before inclusion in the study.
研究组 & 干预措施
Temozolomide
Experimental
Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
时间窗: 6 months
Progression-free survival as determined by Kaplan-Meier method.
次要结局
未报告次要终点
研究者
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