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

Recurrent High-grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02333513
• Other study ID #: YDCR-2014-006
• Secondary ID: ChiCTR-OOC-15005
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2015
• Last updated: April 8, 2015
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2015
• Source: Hebei Yanda Hospital
• Contact: Nan Ji, Medical Doctor
• Phone: +86 15210503095
• Email: neurochina[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Recurrent High-grade Glioma

Intervention

Drug:
• Lomustine/Vincristine/Procarbazine

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Hebei Yanda Hospital	Sanhe	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yanda Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		12 months or later	No
Secondary	6-month progression-free survival rate		6 month	No
Secondary	12-month progression-free survival rate		12 month	No
Secondary	6-month survival rate		6 month	No
Secondary	12-month survival rate		12 month	No
Secondary	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	No
Secondary	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	No