Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas

Study Overview
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Brief Summary
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Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet. The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas

Official Title
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Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study

Conditions
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Malignant Gliomas

Intervention / Treatment
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* Drug: TMZ
* Drug: TMZ plus CDDP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age>=18 and <=70years old Histological diagnosis of malignant gliomas(WHO III or IV) The status of methylation of promotor of MGMT should be detected. The time to be enrolled should be more than 90 days after the irradiation. The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment. Performance status(Karnofsky index)>=60 Life expectancy more than 3 months Exclusion Criteria: Ages:< 18 years or > 70 years Abnormal function of liver or renal(value more than 1.5 fold normal upper limit ) Blood routing: Hb < 100g/l， WBC < 4.0×109/l; PLT < 100×109/l Pregnant or lactating women Allergic to administered drugs Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment. Life expectancy less than 3 months Participation in other clinical trials in the 90previous days before enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TMZ group<br>patients were treated with TMZ alone | Drug: TMZ<br>* patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles<br>* Other names: temozolomide;|
| Experimental: TMZ plus CDDP group<br>patients were treated with TMZ plus CDDP | Drug: TMZ plus CDDP<br>* patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles<br>* Other names: temozolomide and cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| over all survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temozolomide(TMZ), cisplatin(CDDP), recurrent malignant gliomas