Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128700
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy together with vatalanib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of vatalanib when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: temozolomide Drug: vatalanib Procedure: adjuvant therapy Radiation: radiation therapy Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study on Concomitant and Adjuvant Temozolomide and Radiotherapy With or Without PTK787/ZK222584 in Newly Diagnosed GBM
Study Start Date : June 2005
Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Dose-limiting toxicity and maximum tolerated dose of vatalanib as determined by CTCAE v3.0 during phase I
  2. Progression-free survival at 6 months during phase II

Secondary Outcome Measures :
  1. Severe toxic events as assessed by CTCAE v3.0 at weeks 3 and 6 (concomitant treatment), weeks 2 and 4 after radiotherapy, before each course of adjuvant treatment, monthly during maintenance treatment, and every 3 months during follow-up in phase II
  2. Overall survival at 1 year during phase II
  3. Correlation of angiogenesis and hypoxia markers expression and O-6-methylguanine DNA methyltransferase (MGMT) methylation status with clinical outcome during phase II

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed glioblastoma multiforme

    • Newly diagnosed disease
  • Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator



  • 18 to 69

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • ALT and AST < 2.5 times ULN


  • Creatinine ≤ 1.7 mg/dL


  • Cardiac function clinically normal
  • 12-lead ECG normal
  • No ischemic heart disease within the past 6 months
  • No uncontrolled cardiac arrhythmia
  • No uncontrolled hypertension
  • No history of stroke
  • No history of congenital long QT syndrome
  • QTc interval ≤ 450 msec for males or ≤ 470 msec for females by 12-lead ECG


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma in situ of the cervix
  • No active uncontrolled infection
  • No other unstable systemic disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up schedule


Biologic therapy

  • No prior anti-vascular endothelial growth factor therapy


  • No prior chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry


  • No prior radiotherapy


  • More than 8 days, but < 6 weeks, since prior surgery or biopsy


  • No prior randomization on this study
  • No concurrent warfarin, warfarin-derived drugs, or similar anticoagulants
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent enzyme inducing antiepileptic drugs, including any of the following:

    • Carbamazepine
    • Fosphenytoin
    • Oxcarbazepine
    • Phenobarbital
    • Phenytoin
    • Primidone
  • No concurrent grapefruit or grapefruit juice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128700

U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3075 EA
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Alba A. Brandes, MD Azienda Ospedaliera di Padova

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00128700     History of Changes
Other Study ID Numbers: EORTC-26041-22041
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors