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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01670890

Enrollment

120

Registered

2012-08-22

Start date

2012-08-31

Completion date

Unknown

Last updated

2012-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Gliomas

Keywords

temozolomide(TMZ), cisplatin(CDDP), recurrent malignant gliomas

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

Interventions

DRUGTMZ

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

DRUGTMZ 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
over all survival	1 year

Secondary

Measure	Time frame
progression free survival	6 months

Countries

China

Contacts

Primary Contactwang renzhi, MD

wangrz@126.com86-010-69156071

Backup ContactWang yu, MD

kingrichwy@126.com86-010-69156071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026