Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00360945
First received: August 3, 2006
Last updated: February 6, 2009
Last verified: November 2006
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate after 2 courses [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Relapse-free survival [ Designated as safety issue: No ]
- Best response in patients receiving more than 2 courses [ Designated as safety issue: No ]
- Rate of progression at 6 months and 1 and 2 years [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 87 |
| Study Start Date: | April 2004 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 4 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360945
Locations
| France | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| 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 | |
| Great Ormond Street Hospital for Children NHS Trust | |
| London, England, United Kingdom, WC1N 3JH | |
| Middlesex Hospital | |
| London, England, United Kingdom, W1T 3AA | |
| 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
Investigators
| Investigator: | Steve Lowis, MD, PhD, BA, MRCP, MRCPCH | Bristol Royal Hospital for Children |
| Investigator: | Jacques Grill, MD, PhD | Institut Gustave Roussy |
| Investigator: | Anthony Michalski, MD | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Investigator: | David A. Walker | Queen's Medical Centre |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00360945 History of Changes |
| Other Study ID Numbers: | CDR0000482280, CCLG-CNS-2004-02, EU-20622 |
| Study First Received: | August 3, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
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:
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Temozolomide Cisplatin Dacarbazine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013