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

August 21, 2012 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • wang ren zhi, MD
          • Phone Number: 86-010-69156071
          • Email: wangrz@126.com
        • Principal Investigator:
          • Ma wen bin, MD
        • Sub-Investigator:
          • wang yu, MD
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital Affiliated to Capital Medial University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin medical university general university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
over all survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tiantan Hospital
Tianjin Medical University General Hospital

Investigators

  • Study Chair: wang renzhi, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pumch-neurosurgery-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Gliomas

Clinical Trials on TMZ

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe