Malignant GliomasPhase 2NCT01670890
Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas
A Phase 2 study testing TMZ and TMZ plus CDDP in people with Malignant Gliomas, run by Peking Union Medical College Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Gliomas
- What is being tested?
- TMZ and TMZ plus CDDP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medial University
Beijing, Beijing Municipality, 100050
Jiang tao, MD, 86-010-67021832, jiangtao369@sohu.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
wang ren zhi, MD, 86-010-69156071, wangrz@126.com
Ma wen bin, MD
- Recruiting
Tianjin medical university general university
Tianjin, Tianjin Municipality, 300052
Yang xue jun, MD, ydenny@yahoo.com
About this study
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
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
- Conditions
- Malignant Gliomas
- Being tested
- TMZ, TMZ plus CDDP
- Keywords
- temozolomide(TMZ), cisplatin(CDDP), recurrent malignant gliomas
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMZDrug
Also called temozolomide
patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
TMZ plus CDDPDrug
Also called temozolomide and cisplatin
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
| Study group | Role | What they receive |
|---|---|---|
| TMZ group | Active comparator | patients were treated with TMZ alone Receives: Drug: TMZ |
| TMZ plus CDDP group | Experimental | patients were treated with TMZ plus CDDP Receives: Drug: TMZ plus CDDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
over all survival
Measured: 1 year
Secondary outcomes (1)
progression free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomasStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
- Investigators
- wang renzhi, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670890
- Sponsor's protocol ID
- pumch-neurosurgery-01
- Status last verified
- Aug 2012
- First submitted
- 19 Aug 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01670890
- Acronym / sponsor ID
- pumch-neurosurgery-01
- Conditions
- Malignant Gliomas
- Keywords
- temozolomide(TMZ), cisplatin(CDDP), recurrent malignant gliomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Tianjin Medical University General Hospital
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMZ group | Active comparator | Drug: TMZpatients were treated with TMZ alone |
| TMZ plus CDDP group | Experimental | Drug: TMZ plus CDDPpatients were treated with TMZ plus CDDP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMZAlso: temozolomidepatients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles | Drug | TMZ group |
| TMZ plus CDDPAlso: temozolomide and cisplatinpatients 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 | Drug | TMZ plus CDDP group |
Primary outcome
over all survival
Time frame: 1 year
1 secondary outcome
progression free survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wang renzhi, MD study chair
Peking Union Medical College Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMZ and TMZ plus CDDP in people with Malignant Gliomas, run by Peking Union Medical College Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang renzhi, MD (86-010-69156071, wangrz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
over all survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.