EUCTR2009-011898-33-DE进行中（未招募）1 期
Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents - A Phase II Study - HIT-HGG-CilMetro
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of high-grade malignant glioma confirmed by central neuropathological review (last MRI diagnosis not older than 4 weeks) - including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (analogous to WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV) - or diagnosis of diffuse intrinsic pontine glioma confirmed by central neuroradiological review - refractory to standard treatment, or relapsed or progressive after first-line therapy.
- •2. Patient aged 3 years and older but under 18 years at time of relapse diagnosis
- •3. Written informed consent of the patient (mandatory from 15 years of age) or the parents (mandatory till 18 years of age).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known hypersensitivity or contraindication to any study drugs
- •2. Other (simultaneous) malignancies
- •3. Pregnancy and / or lactation
- •4. Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
- •5. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- •6. Severe concomitant diseases (e.g. immune deficiency syndrome) or HIV infection
- •7. Severe psychological disease or neurological damage without possibility to communicate
- •8. Clinical signs of intracranial pressure
- •9. Intracerebral hemorrhage or history of intracerebral hemorrhage
- •10. Following laboratory test results (not older than 2 weeks before patient´s inclusion):
- •Platelets < 100 000/µl (< 100 Gpt/l)
- •PT, INR and PTT above normal range
- •Absolute neutrophil count = 1 500/µl (< 1,5 Gpt/l)
- •Hemoglobin < 10g/dl (< 6,4 mmol/L)
- •Serum creatinine = 1,5 x upper limit of normal range or creatinine clearance rate = 60 ml/min/m2 (corrected for body surface area)
- •Total bilirubin = 1,5 x upper limit of normal range
- •SGOT (ASAT) and SGPT (ALAT) = 2,5 x upper limit of normal range
- •Alkaline phosphatase = 2,5 x upper limit of normal range
- •11. Hereditary Intrinsic Platelet Disorders
- •12.Ongoing irradiation or chemotherapy (within the last 4 weeks)
- •13. Estimated life expectancy of less than 2 months
研究者
相似试验
进行中（未招募）
不适用
Cilengitide (EMD121974) and temozolomide with concomitant radiation therapy, followed by cilengitide and temozolomide maintenance therapy in subjects with newly diagnosed glioblastoma multiforme – a multicenter, open-label, uncontrolled Phase I/IIa studyEUCTR2004-004849-18-DEMerck KGaA50
进行中（未招募）
不适用
Cilengitide (EMD121974) and temozolomide with concomitant radiation therapy, followed by cilengitide and temozolomide maintenance therapy in subjects with newly diagnosed glioblastoma multiforme – a multicenter, open-label, uncontrolled Phase I/IIa studyewly diagnosed Glioblastoma (Astrocytoma, WHO grade IV)MedDRA version: 7.1Level: LLTClassification code 10018336EUCTR2004-004849-18-BEMerck KGaA50
终止
2 期
Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and AdolescentsGliomasNCT01517776Martin-Luther-Universität Halle-Wittenberg28
已完成
2 期
Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant GliomaJPRN-UMIN000040599Department of Neurosurgery, Hirosaki University School of Medicine50
进行中（未招募）
不适用
A Phase II study of Temozolomide (Temodal) Given Continously 100mg/m2 for 21 Days in 28 Day cycles in Patients with Metastatic Melanoma.Metastatic melanomaEUCTR2004-002925-39-SEKliniken för onkologi, Karolinska Universitetssjukhuset, Solna35