ISRCTN70044565已完成未知
A dose-finding study of the safety and tolerability of intravenous reovirus (REOLYSIN®) (pelareorep) plus granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with standard of care chemoradiotherapy (CTRT) /adjuvant chemotherapy for Glioblastoma Multiforme (GBM)
niversity of Leeds0 个研究点目标入组 24 人开始时间: 2017年2月6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
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects with a histologically confirmed diagnosis of Glioblastoma Multiforme (WHO Grade IV, including variants).
- •2. Previous biopsy or debulking surgery.
- •3. Trial treatment must start within a maximum of 42 days (6 weeks) after biopsy/surgery.
- •4. Eligible for first line standard treatment with Stupp regimen (radiotherapy concomitant with temozolomide followed by adjuvant temozolomide)
- •5. If the participant is receiving dexamethasone (or equivalent) this must be a maximum of 8mg dexamethasone daily (or equivalent)
- •6. Aged over 16
- •7. ECOG performance status 0-1 (see appendix 2)
- •8. Life expectancy = 4 months
- •9. Required laboratory values within 7 days prior to registration
- •9.1. Absolute neutrophil count (ANC) = 1.5 x 109 [SI units 109/L]
- •9.2. Platelets =100 x109 [SI units 109/L] (without platelet transfusion)
- •9.3. Haemoglobin =9.0 g/dL [SI units gm/L] (with or without RBC transfusion)
- •9.4. Serum creatinine =1.5 x upper limit of normal (ULN)
- •9.5. Bilirubin =1.5 x ULN
- •9.6. AST/ALT =2.5 x ULN
- •10. Proteinuria = Grade 1 or Urinary protein < 1 g/24hr
- •11. Ability to provide written informed consent prior to participating in the trial and any trial-related procedures being performed.
- •12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and any other trial procedures.
- •13. Female participants of child-bearing potential must agree to use dual methods of contraception for the duration of the trial . Male participants must agree to use dual methods of contraception for the duration of the trial and for 6 months after the last dose of trial treatment is received if sexually active with a female of child-bearing potential.
排除标准
- •1. Pregnant (positive pregnancy test, serum or urine acceptable) or breast feeding
- •2. Previous treatment for GBM other than debulking surgery
- •3. Concurrent or previous malignancies (< 12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Participants with histories (> = 12 months) of other tumours may be entered
- •4. Patients seropositive for HIV, Hepatitis B or C infection
- •5. Immunosuppressive therapy other than steroids (maximum of 8mg daily dexamethasone or equivalent)
- •6. Any history of hypersensitivity to any of the trial medications or excipients
- •7. Participants with active uncontrolled infections
- •8. Participants with peripheral neuropathy > = CTC grade 3
- •9. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial
- •10. Patients with the following significant cardiovascular diseases within 1 year of consent; history of arrhythmia, myocardial infarction, symptomatic heart failure, uncontrolled hypertension, or history of QTc abnormalities
- •11. Participants must not have received G-CSF since confirmed diagnosis of Glioblastoma Multiforme
研究者
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