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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01670890

Collaborator

Beijing Tiantan Hospital (Other), Tianjin Medical University General Hospital (Other)

120

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Malignant Gliomas	Drug: TMZ Drug: TMZ plus CDDP	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TMZ group patients were treated with TMZ alone	Drug: TMZ patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles Other Names: temozolomide
Experimental: TMZ plus CDDP group patients were treated with TMZ plus CDDP	Drug: 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 Other Names: temozolomide and cisplatin

Arm

Intervention/Treatment

Active Comparator: TMZ group

patients were treated with TMZ alone

Drug: TMZ

patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles

Other Names:

temozolomide

Experimental: TMZ plus CDDP group

patients were treated with TMZ plus CDDP

Drug: 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

Other Names:

temozolomide and cisplatin

Outcome Measures

Primary Outcome Measures

over all survival [1 year]

Secondary Outcome Measures

progression free survival [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital Affiliated to Capital Medial University	Beijing	Beijing	China	100050
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
3	Tianjin medical university general university	Tianjin	Tianjin	China	300052