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Status:

COMPLETED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18-69 years

Phase:

PHASE1

PHASE2

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 ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of vatalanib when given in combination with temozolomide and radiotherapy in patients with newly diagnosed gl...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed glioblastoma multiforme
  • Newly diagnosed disease
  • Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 69
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase \< 2.5 times ULN
  • ALT and AST \< 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.7 mg/dL
  • Cardiovascular
  • 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
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior anti-vascular endothelial growth factor therapy
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • More than 8 days, but \< 6 weeks, since prior surgery or biopsy
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT00128700

    Start Date

    June 1 2005

    Last Update

    September 24 2012

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    U.Z. Gasthuisberg

    Leuven, Belgium, B-3000

    2

    Klinikum der Universitaet Regensburg

    Regensburg, Germany, D-93053

    3

    Azienda Ospedaliera di Padova

    Padua, Italy, 35128

    4

    Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, Netherlands, 3075 EA