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

Malignant Gliomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01670890
• Other study ID #: pumch-neurosurgery-01
• Status: Recruiting
• Phase: Phase 2
• First received: August 19, 2012
• Last updated: August 21, 2012
• Start date: August 2012

Study information

• Verified date: August 2012
• Source: Peking Union Medical College Hospital
• Contact: wang renzhi, MD
• Phone: 86-010-69156071
• Email: wangrz[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Malignant Gliomas

Intervention

Drug:
• TMZ
patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
• TMZ plus CDDP
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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medial University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Tianjin medical university general university	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Tiantan Hospital, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	over all survival		1 year	No
Secondary	progression free survival		6 months	No