Status:
UNKNOWN
Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
4-20 years
Phase:
PHASE2
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. Givi...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate (complete and partial response) in pediatric patients with malignant gliomas treated with temozolomide and cisplatin. Secondary * Identi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00360945
Start Date
April 1 2004
Last Update
September 17 2013
Active Locations (23)
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1
Institut Gustave Roussy
Villejuif, France, F-94805
2
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
3
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
4
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE