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

Hebei Yanda Hospital

Status: Unknown

Conditions: Recurrent High-grade Glioma

Treatments: Drug: Lomustine/Vincristine/Procarbazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02333513

YDCR-2014-006

ChiCTR-OOC-15005759 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

case group

Experimental group

Treatment:

Drug: Lomustine/Vincristine/Procarbazine