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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Malignant Gliomas

Treatments: Drug: TMZ plus CDDP; Drug: TMZ

Study type: Interventional

Funder types: Other

Identifiers

NCT01670890

pumch-neurosurgery-01

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

TMZ group

Active Comparator group

Description:

patients were treated with TMZ alone

Treatment:

Drug: TMZ

TMZ plus CDDP group

Experimental group

Description:

patients were treated with TMZ plus CDDP

Treatment:

Drug: TMZ plus CDDP