EUCTR2007-000179-41-GB进行中（未招募）不适用
Intrathecal chemotherapy with liposomal ara-C (Depocyte) in leptomeningeal metastases of solid tumors: a phase III study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •Patients with histological proof of lung or breast cancers.
- •Newly diagnosed leptomeningeal metastases confirmed by positive lumbar cerebrospinal fluid (CSF) cytology obtained within 21 days prior to registration (in case of characteristic signs and symptoms plus a suspected MRI or CT finding, two negative CSF cytology should be obtained to exclude these patients).
- •Patients must be fit for IT treatment via the lumbar route.
- •= 18 years and = 70 years
- •KPS 70-100.
- •Adequate hematological, renal, hepatic function
- •Platelet count= 75 x 10exp9/L
- •ANC= 1 x 10 exp9/L
- •Serum creatinine = 1.5 x upper limit of normal (ULN)
- •Total bilirubin= 3 x ULN
- •SGOT (AST)= 2.5 x ULN
- •= 5 x ULN in case of hepatic metastasis
- •LDH= 2.5 x ULN
- •= 5 x ULN in case of hepatic metastasis
- •All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner).
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •All registered patients should undergo a CSF flow study, but only patients without significant CSF blocks are eligible for randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Leptomeningeal metastases from hematological malignancies.
- •Patients with leptomeningeal metastases from primary CNS tumors.
- •Patients with a clinically manifest encephalopathy interfering with every day activities like dressing.
- •No clinically symptomatic brain metastases (unless related to the leptomeningeal metastases: lesions (with a width of <2 cm) in continuity with the subarachnoid space are eligible.)
- •Patients with rapidly progressive systemic disease or extensive systemic disease with limited survival expectancy i.e. patients with a life expectancy of less than 3 months.
- •blood clotting disorders, interfering with lumbar punctures. Patients should not be under any anticoagulant treatment including low molecular weight heparins, but low dose prophylactic treatment with low molecular weight heparins is allowed.
- •prior treatment with systemic ARA-C.
- •Patients should not have received prior neuraxis radiotherapy.
- •prior IT treatment.
- •ventricular peritoneal (or similar) CSF drain.
- •active systemic or CSF infection.
- •known hypersensitivity to ARA-C or DepoCyte®.
- •Other concurrent investigational agent during the study (leptomeningeal CNS disease would be anyway an exclusion criteria for most trials on investigational agents).
- •Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the baseline visit)
- •Females must not be pregnant (pregnancy test) or lactating.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
研究者
相似试验
进行中（未招募）
不适用
Intrathecal chemotherapy with liposomal ara-C (Depocyte) in leptomeningeal metastases of solid tumors: a phase III studyEUCTR2007-000179-41-BEMundipharma Research Ltd152
进行中（未招募）
不适用
Chimiothérapie intra-arterielle lipiodolée (CIAL) versus chimiothérapie systémique par gemcitabine et oxaliplatine (GEMOX) versus surveillance simple après résection ou destruction des carcinomes hépatocellulaires sur cirrhose - GEMOXIAcarcinome hépatocellulaire sur cirrhoseMedDRA version: 8.1Level: PTClassification code 10051571Term: carcinome hépatocellulaire sur cirrhoseEUCTR2006-005456-32-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
已完成
3 期
Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasis of Breast CancerLeptomeningeal MetastasesBreast CancerNCT01645839Centre Oscar Lambret74
进行中（未招募）
不适用
intrarterial chemotherapy with liposomial doxorubicin for recurrent glioblastoma affected patients. Phase II study. - intrarterial cht with myocet for recurrent glioblastomarecurrence of high grade glioblastomaMedDRA version: 9.1Level: LLTClassification code 10018336Term: GlioblastomaEUCTR2008-002454-37-ITISTITUTO NAZIONALE PER LA CURA TUMORI
进行中（未招募）
不适用
Combined systemic an intrathecal chemotherapy with succeeding high dosis chemotherapy and autologous stem cell transplantation of patients with CNS relapses of agressive lymphomas. - NHL-ZNS-RezidivThe aim of the study is the prospective verification of effectiveness and compatibility of a systemic therapy with CNS passable cytostatics (high-dose Methotrexat and Ifosfamide, and high-dose Cytarabine and Thiothepa) combined with an intrathecal Depocyte therapy, followed by a High-dose dose chemotherapy with Carmustine, Thiothepa and Etoposid and an autologous stem cell transplantation.EUCTR2006-006516-30-DECharité-Universitätsmedizin Berlin