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Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma

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: NCT00360945
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2006
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: cisplatin Drug: temozolomide Genetic: fluorescence in situ hybridization Genetic: loss of heterozygosity analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Radiation: radiation therapy Phase 2

Detailed Description:



  • Determine the objective response rate (complete and partial response) in pediatric patients with malignant gliomas treated with temozolomide and cisplatin.


  • Identify genetic, metabolic, and proteomic profiles that will provide an insight into the molecular pathways involved in the pathogenesis of these tumors.
  • Link genetic changes with clinical details, histopathology, and patient outcome, thereby developing a biological basis for diagnosis, prognosis, and treatment monitoring.
  • Evaluate relapse-free survival at 1 and 2 years in patients treated at diagnosis.
  • Evaluate the duration of clinical response in patients treated at relapse.
  • Study the health status and quality of life of these patients.
  • Evaluate long-term toxicity of this therapeutic combination.
  • Evaluate the ability of magnetic resonance spectroscopy vs CT scan to predict response in patients with high-grade astrocytomas.

OUTLINE: This is a multicenter, open-label, nonrandomized, parallel-group study. Patients are stratified according to disease status (newly diagnosed vs relapsed). Patients with newly diagnosed disease are further stratified according to spread of disease (localized and measurable vs diffuse unmeasurable).

  • Stratum I (newly diagnosed disease): Patients receive CISTEM chemotherapy comprising cisplatin IV over 3 hours on day 1 and oral temozolomide once daily on days 2-6. Treatment repeats every 28 days for up to 7 courses. Patients who achieve responsive or stable disease after 2 courses receive 2 more courses of CISTEM chemotherapy and then undergo radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients may receive up to 3 more courses of CISTEM chemotherapy for a total of 7 courses.
  • Stratum II (relapsed disease): Patients receive CISTEM chemotherapy for up to 7 courses as in stratum I. Patients who reach the maximum dose allowed for cisplatin may receive oral temozolomide alone indefinitely.

Tissue and blood samples are obtained at baseline and examined by immunohistochemistry, fluorescent in situ hybridization (FISH), and loss of heterozygosity. The tumor tissue is analyzed for p53, MSH2, MLH1, and MGMT.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
Study Start Date : April 2004

Primary Outcome Measures :
  1. Response rate after 2 courses

Secondary Outcome Measures :
  1. Relapse-free survival
  2. Best response in patients receiving more than 2 courses
  3. Rate of progression at 6 months and 1 and 2 years
  4. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors*:

    • Glioblastoma
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic oligoastrocytoma
    • Anaplastic ganglioglioma
    • Anaplastic mixed tumor

      • Glial component is essential NOTE: *Malignant gliomas occurring as a second primary malignancy allowed
  • Newly diagnosed or recurrent disease
  • No malignant brain stem tumors
  • Incompletely resected tumors

    • No completely resected tumors
  • Measurable or evaluable disease by conventional MRI


  • Lansky performance status 40-100%
  • Organ toxicity ≤ grade 2
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Prothrombin ≥ 50%
  • Fibrinogen ≥ 1.5 g/L
  • Creatinine normal for age

    • Creatinine ≤ 65 µmol/L (4-15 years of age)
    • Creatinine ≤ 110 µmol/L (15-20 years of age)
  • Audiogram with toxicity grade ≤ 2
  • ECG normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe or life-threatening infection
  • No uncontrolled developing or symptomatic intracranial hypertension


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease
  • No prior cisplatin or temozolomide
  • No other concurrent anticancer therapy

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): NCT00360945

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Institut Gustave Roussy
Villejuif, France, F-94805
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
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OverallOfficial: Steve Lowis, MD, PhD, BA, MRCP, MRCPCH Bristol Royal Hospital for Children
OverallOfficial: Jacques Grill, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
OverallOfficial: Anthony Michalski, MD Great Ormond Street Hospital for Children NHS Foundation Trust
OverallOfficial: David A. Walker Queen's Medical Centre

Layout table for additonal information Identifier: NCT00360945     History of Changes
Other Study ID Numbers: CDR0000482280
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
childhood oligodendroglioma
untreated childhood cerebellar astrocytoma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood brain tumor

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action