Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas
This study is currently recruiting participants.
Verified August 2012 by Peking Union Medical College Hospital
Sponsor:
Peking Union Medical College Hospital
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
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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
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 Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013