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临床试验/EUCTR2006-004377-99-DE
EUCTR2006-004377-99-DE进行中（未招募）不适用

Phase I study of Somatostatin-Analogues as Second Line Treatment in Adult Patients with Recurrent Medulloblastoma (WHO IV)

Medizinische Einrichtungen des Bezirks Oberpfalz GmbH0 个研究点开始时间: 2006年9月22日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

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

  • •Histologically confirmed diagnosis of medulloblastoma/PNET WHO grade IV with confirmatory histology (german reference center for neuropathology, Bonn).
  • •Age: 18-70 years.
  • •Karnofsky performance status of at least 70 %
  • •Positive somatostatin receptor status (111In-octreotide scintigraphy).
  • •Measurable lesion (including cysts and/or necrotic areas) with a maximum diameter of 4,5 cm documented by MRI (note: exception for resection defect located within a measured lesion: if volume of defect > 20 % of volume of the respective measured lesion, a maximum diameter of 6,0 cm is allowed).
  • •Lesion (or sum of lesions) does not exceed 50 cm3 in volume.
  • •Standard treatment (1. debulking surgery, 2. craniospinal irradiation [with approx. 35 Gy] + boost to the posterior fossa [total approx. = 50 Gy], 3. Chemotherapy with at least 1 regimen finished.
  • •Prior chemotherapy finished at least 4 weeks prior to study entry.
  • •Adequate hepatic, renal and bone marrow function as defined by the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x ULN, creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L and Hb >10g/dL.
  • •Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study drug dosing. Pregnancy tests will be repeated every 4 weeks at the start of every cycle (to be clarified by CROLLL). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential who agree to employ an effective barrier method of birth control throughout the study, and for up to 3 months following discontinuation of study drug.
  • •Clinically normal cardiac function without history of ischaemic heart disease in the past 6 months with normal 12 lead ECG and absence of uncontrolled cardiac arrythmias.
  • •Ensured compliance: The patient should be able to cooperate with the protocol regulations and follow-up.
  • •Signed informed consent prior to initiation of any study procedure.
  • •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

  • •Symptomatic gallstones
  • •Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
  • •Patients receiving EIADs (Patients under EIADS should be switched to no EIADs prior to study entry).
  • •Active infection of HIV, HBV, HCV; clinically significant acute viral, bacterial, or fungal infection
  • •Acute medical problems that may be considered to become an unacceptable risk, or any conditions which might be contraindications for starting study treatment.
  • •History of allergies to reagents used in this study.
  • •Drug abuse or extensive use of alcohol.
  • •Patient has received any other investigational agent within 28 days of first day of study drug dosing.
  • •Patient receive any other somatostatin analogues
  • •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

发起方
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH

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