Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
Verified date | November 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 87 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 20 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Institut Gustave Roussy | Villejuif | |
Ireland | Our Lady's Hospital for Sick Children Crumlin | Dublin | |
United Kingdom | Royal Aberdeen Children's Hospital | Aberdeen | Scotland |
United Kingdom | Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland |
United Kingdom | Birmingham Children's Hospital | Birmingham | England |
United Kingdom | Bristol Royal Hospital for Children | Bristol | England |
United Kingdom | Institute of Child Health at University of Bristol | Bristol | England |
United Kingdom | Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England |
United Kingdom | Childrens Hospital for Wales | Cardiff | Wales |
United Kingdom | Royal Hospital for Sick Children | Edinburgh | Scotland |
United Kingdom | Royal Hospital for Sick Children | Glasgow | Scotland |
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 | Great Ormond Street Hospital for Children NHS Trust | London | England |
United Kingdom | Middlesex Hospital | 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 |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer and Leukaemia Group |
France, Ireland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate after 2 courses | No | ||
Secondary | Relapse-free survival | No | ||
Secondary | Best response in patients receiving more than 2 courses | No | ||
Secondary | Rate of progression at 6 months and 1 and 2 years | No | ||
Secondary | Overall survival | No |
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