A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

Study Overview
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Brief Summary
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This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.

Detailed Description
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This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code ChiCTR-OOC-15005759 in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.

Official Title
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A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

Conditions
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Recurrent High-grade Glioma

Intervention / Treatment
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* Drug: Lomustine/Vincristine/Procarbazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing. The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed. The age of the patient is between 18 years old and 70 years old. The condition of the patient permits the procedure of chemotherapy using PCV schema. The patient is informed consent, and willing to join in this research. Exclusion Criteria: The diagnosis is not recurrent high-grade glioma. The diagnosis of high-grade glioma was not established by pathological method. No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist. The age of the patient does not meet the requirement of this research. The condition of the patient does not permit the procedure of chemotherapy using PCV schema. There are other conditions that the clinicians believe that the PCV chemotherapy is not appropriate for the patient. The patient is not willing to join in this research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: case group<br> | Drug: Lomustine/Vincristine/Procarbazine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 12 months or later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression-free survival rate |  | 6 month | 
| 12-month progression-free survival rate |  | 12 month | 
| 6-month survival rate |  | 6 month | 
| 12-month survival rate |  | 12 month | 
| 6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods |  | 6 month | 
| 12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods |  | 12 month |