ISRCTN23008679已完成未知
Bevacizumab in combination with metronomic dose temozolomide in patients with relapsed high grade gliomas
Academic Medical Centre (AMC) (The Netherlands)0 个研究点目标入组 23 人开始时间: 2007年7月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
2010 results in https://pubmed.ncbi.nlm.nih.gov/20064829/ (added 10/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients present with histologically confirmed diagnosis of intracranial recurrent high grade glial tumour (World Health Organisation [WHO] grade IV). Patients may be entered based on local pathology from the original tumour specimen
- •2. Patients must have evidence of tumour progression following radiation and chemotherapy as measured by Magnetic Resonance Imaging (MRI) (MRI-0 at presentation)
- •3. Patients may have received up to two prior chemotherapy regimens (with concurrent radiotherapy)
- •4. Patients may have undergone prior surgical resection and will be eligible if recovered from the effects of surgery
- •5. Patients must have adequate organ function, including the following:
- •5.1. Adequate bone marrow reserve: Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L, platelet count greater than 100 x 10^9/L, and haemoglobin greater than g/dL (6.21 mmol/L)
- •5.2. Hepatic: total bilirubin less than two times the Upper Limit of Normal (ULN); Alkaline Phosphatase (ALP), Aspartate Transaminase (AST), and Alanine Transaminase (ALT) less than 3 x ULN
- •5.3. Renal: serum creatinine less than 1.5 ULN
- •These tests must be performed less than five days prior to enrolment. Eligibility for haemoglobin count may be reached by transfusion
- •6. Patients must have a Karnofsky Performance Score greater than 70%
- •7. Patients must be greater than 18 years of age, with a life expectancy of greater than eight weeks
- •8. Patient compliance and geographic proximity that allow for adequate follow up is required
- •9. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, Intrauterine Device [IUD], birth control pills, or barrier device) during and for three months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test less than three days prior to study enrolment
- •10. Signed informed consent from the patient or legal representative is required
排除标准
- •1. Patients with inability to comply with protocol or study procedures (for example, an inability to swallow tablets)
- •2. Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •3. Patients receiving EIAEDs (Enzyme-Inducing Anti-Epileptic Drugs). Patients must discontinue EIAEDs greater than 14 days prior to study enrolment. The investigator may prescribe non-EIAEDs
- •4. Patients receiving any other anticancer therapy, any anticoagulant therapy
- •5. Patients with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram indicative of cardiac disease) that, in opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
- •6. Patients with prior thrombo-embolic events
研究者
相似试验
已完成
不适用
Avastin and Temozolomide attacking Relapsed GliomagliomabevacizumabtemozolomidePFS6NL-OMON26843Prof.dr. D.J. Richel30
尚未招募
2 期
Bevacizumab in combination with metronomic dose temozolomide in patients with relapsed high grade gliomasbrain tumorRecurrent high grade glial tumors10029211NL-OMON30453Academisch Medisch Centrum30
进行中（未招募）
不适用
Bevacizumab in combination with metronomic dose temozolomide in patients with relapsed high grade gliomas - BEvacizumab + TEmozolomide in Relapsed gliomaPatients with a recurrent high grade glioma (after primary treatment)MedDRA version: 9.1Level: LLTClassification code 10018338Term: GliomaEUCTR2007-000488-38-NLAcademic Medical Center
已完成
2 期
Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung CancerNon Small Cell Lung CancerNCT00755170Hellenic Oncology Research Group48
撤回
2 期
Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung CancerSmall Cell Lung CancerNCT00755157University Hospital of Crete