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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Recurrent High-grade Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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case group

Group Type EXPERIMENTAL

Lomustine/Vincristine/Procarbazine

Intervention Type DRUG

Interventions

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Lomustine/Vincristine/Procarbazine

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No