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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Tianjin Medical University General Hospital
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01670890
First received: August 19, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Malignant Gliomas
Drug: TMZ
Drug: TMZ plus CDDP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • over all survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: temozolomide and cisplatin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670890

Contacts
Contact: wang renzhi, MD 86-010-69156071 wangrz@126.com
Contact: Wang yu, MD 86-010-69156071 kingrichwy@126.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: wang ren zhi, MD    86-010-69156071    wangrz@126.com   
Principal Investigator: Ma wen bin, MD         
Sub-Investigator: wang yu, MD         
Beijing Tiantan Hospital Affiliated to Capital Medial University Recruiting
Beijing, Beijing, China, 100050
Contact: Jiang tao, MD    86-010-67021832    jiangtao369@sohu.com   
China, Tianjin
Tianjin medical university general university Recruiting
Tianjin, Tianjin, China, 300052
Contact: Yang xue jun, MD       ydenny@yahoo.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tiantan Hospital
Tianjin Medical University General Hospital
Investigators
Study Chair: wang renzhi, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01670890     History of Changes
Other Study ID Numbers: pumch-neurosurgery-01
Study First Received: August 19, 2012
Last Updated: August 21, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
temozolomide(TMZ)
cisplatin(CDDP)
recurrent malignant gliomas

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014