Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma
NCT ID: NCT00360945
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
87 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.
Detailed Description
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Primary
* Determine the objective response rate (complete and partial response) in pediatric patients with malignant gliomas treated with temozolomide and cisplatin.
Secondary
* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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cisplatin
temozolomide
fluorescence in situ hybridization
loss of heterozygosity analysis
immunohistochemistry staining method
laboratory biomarker analysis
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* 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
4 Years
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Steve Lowis, MD, PhD, BA, MRCP, MRCPCH
Role:
Bristol Royal Hospital for Children
Jacques Grill, MD, PhD
Role:
Gustave Roussy, Cancer Campus, Grand Paris
Anthony Michalski, MD
Role:
Great Ormond Street Hospital for Children NHS Foundation Trust
David A. Walker
Role:
Queen's Medical Center
Locations
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Institut Gustave Roussy
Villejuif, , France
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Middlesex Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-CNS-2004-02
Identifier Type: -
Identifier Source: secondary_id
EU-20622
Identifier Type: -
Identifier Source: secondary_id
CDR0000482280
Identifier Type: -
Identifier Source: org_study_id