Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma
|ClinicalTrials.gov 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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Masking:||None (Open Label)|
|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|
- Response rate after 2 courses
- Relapse-free survival
- Best response in patients receiving more than 2 courses
- Rate of progression at 6 months and 1 and 2 years
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360945
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Our Lady's Hospital for Sick Children Crumlin|
|Dublin, Ireland, 12|
|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|
|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|
|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|