ISRCTN68738654已完成2 期
Dose-intensified rechallenge with temozolomide, one week on one week off versus three weeks on one week off in patients with progressive or recurrent glioblastoma: a prospective, multicentre, multinational, randomised, parallel-group, open, phase II trial
niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)0 个研究点目标入组 166 人开始时间: 2009年4月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25655102
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/10/2011:
- •1. Progressive or recurrent glioblastoma documented by magnetic resonance imaging (MRI) no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy
- •2. Histological diagnosis of glioblastoma
- •3. Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor of a patient undergoes a surgical procedure at recurrence prior to study entry
- •4. Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
- •5. Informed consent
- •6. Aged 18 - 80 years, either sex
- •7. Karnofsky performance score greater than 50%
- •8. Neutrophil counts greater than 1,500/µl
- •9. Platelet counts greater than 100,000/µl
- •10. Haemoglobin greater than 10 g/dl
- •11. Serum creatinine less than 1.5-fold upper normal range
- •12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than three-fold upper normal range unless attributed to anticonvulsants
- •13. Alkaline phosphatase less than three-fold upper normal range
- •14. Women with childbearing potential must have a negative serum pregnancy test less than or equal to 14 days prior to study enrolment
- •Added 05/10/2011:
- •15. Willingness to apply contraception according to local requirements (as stated in patient information)
- •Previous inclusion criteria:
- •3. Tissue available for the determination of MGMT gene promoter methylation in the recurrent tumour
- •All other points remained unchanged.
排除标准
- •1. Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy
- •2. Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial except that an adjuvant starting dose of 200 mg/m^2 and more than six cycles of adjuvant temozolomide are allowed
- •3. Prior systemic or local treatment with deoxyribonucleic acid (DNA)-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- •4. Allergy to or other intolerability of temozolomide
- •5. Unable to undergo MRI
- •6. Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
- •7. Human immunodeficiency virus (HIV) infection
- •8. Pregnancy
- •9. Breast feeding
- •10. Treatment within in any other clinical trial parallel to the treatment phase of the current study
研究者
相似试验
进行中（未招募）
不适用
Dose Intensified Rechallenge with Temozolomide, One Week on One Week Off versus Three Weeks on One Week Off in Patients with Progressive or Recurrent Glioblastoma (DIRECTOR)EUCTR2008-006871-60-ATniversity Hospital Heidelberg, Ruprechts-Karl-University Heidelberg166
进行中（未招募）
不适用
Dose-intensified Rechallenge with Temozolomide, One Week on One Week Off versus Three Weeks on One Week Off in Patients with Progressive or Recurrent Glioblastoma - DIRECTORprogressive or recurrent glioblastoma after first surgery for glioblastoma and after completion of radiotherapyMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiformeEUCTR2008-006871-60-DEniversity Hospital Heidelberg, Ruprechts-Karl-University Heidelberg166
进行中（未招募）
1 期
Extended schedule, escalated dose Temozolomide versusDacarbazine in Stage IV Metastatic Melanoma: ARandomized Phase III Study of the EORTC MelanomaGroupEUCTR2004-000654-23-ESEORTC850
进行中（未招募）
不适用
Extended schedule, escalated dose Temozolomide versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma GroupStage IV Metastatic MelanomaMedDRA version: 9.1Level: LLTClassification code 10027481Term: Metastatic melanomaEUCTR2004-000654-23-GBEORTC850
进行中（未招募）
不适用
Extended schedule, escalated dose Temozolomide versusDacarbazine in Stage IV Metastatic Melanoma: ARandomized Phase III Study of the EORTC MelanomaGroupStage IV Metastatic MelanomaMedDRA version: 7.0Level: PTClassification code 10027480EUCTR2004-000654-23-BEEORTC850