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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01670890
Other study ID # pumch-neurosurgery-01
Secondary ID
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. completion date
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


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
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Completed NCT00704080 - A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas Phase 1
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Withdrawn NCT02369367 - Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme (Phase II) Phase 2