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

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ClinicalTrials.gov Identifier: NCT01670890
Recruitment Status : Unknown
Verified August 2012 by gwcmc.
Recruitment status was:  Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Tianjin Medical University General Hospital
Information provided by (Responsible Party):
gwcmc

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


Condition or disease Intervention/treatment Phase
Malignant Gliomas Drug: TMZ Drug: TMZ plus CDDP Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. over all survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Beijing Tiantan Hospital Affiliated to Capital Medial University Recruiting
Beijing, Beijing, China, 100050
Contact: Jiang tao, MD    86-010-67021832    jiangtao369@sohu.com   
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         
China, Tianjin
Tianjin medical university general university Recruiting
Tianjin, Tianjin, China, 300052
Contact: Yang xue jun, MD       ydenny@yahoo.com   
Sponsors and Collaborators
gwcmc
Beijing Tiantan Hospital
Tianjin Medical University General Hospital
Investigators
Study Chair: wang renzhi, MD gwcmc

Responsible Party: gwcmc
ClinicalTrials.gov Identifier: NCT01670890     History of Changes
Other Study ID Numbers: pumch-neurosurgery-01
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by gwcmc:
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
Dacarbazine
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action