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

Primary Purpose

Malignant Gliomas

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

TMZ

TMZ plus CDDP

About this trial

This is an interventional treatment trial for Malignant Gliomas focused on measuring temozolomide(TMZ), cisplatin(CDDP), recurrent malignant gliomas

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beijing Tiantan Hospital Affiliated to Capital Medial UniversityRecruiting
Peking Union Medical College HospitalRecruiting
Tianjin medical university general universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TMZ group

TMZ plus CDDP group

Arm Description

patients were treated with TMZ alone

patients were treated with TMZ plus CDDP

Outcomes

Primary Outcome Measures

over all survival

Secondary Outcome Measures

progression free survival

Full Information

NCT ID

NCT01670890

First Posted

August 19, 2012

Last Updated

August 21, 2012

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital, Tianjin Medical University General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01670890

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital, Tianjin Medical University General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Gliomas

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TMZ group

Arm Type

Active Comparator

Arm Description

patients were treated with TMZ alone

Arm Title

TMZ plus CDDP group

Arm Type

Experimental

Arm Description

patients were treated with TMZ plus CDDP

Intervention Type

Drug

Intervention Name(s)

TMZ

Other Intervention Name(s)

temozolomide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TMZ plus CDDP

Other Intervention Name(s)

temozolomide and cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

over all survival

Time Frame

1 year

Secondary Outcome Measure Information:

Title

progression free survival

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wang renzhi, MD

Phone

86-010-69156071

wangrz@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wang yu, MD

Phone

86-010-69156071

kingrichwy@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wang renzhi, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Tiantan Hospital Affiliated to Capital Medial University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiang tao, MD

Phone

86-010-67021832

jiangtao369@sohu.com

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

wang ren zhi, MD

Phone

86-010-69156071

wangrz@126.com

First Name & Middle Initial & Last Name & Degree

Ma wen bin, MD

First Name & Middle Initial & Last Name & Degree

wang yu, MD

Facility Name

Tianjin medical university general university

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang xue jun, MD

ydenny@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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