Overview

A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Criteria
Inclusion Criteria:

- - Page 3 of 4 [DRAFT] - Arms Assigned Interventions

- Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients
will be received 6 cycle of temozolomide plus α-IFN α-IFN: 3mIU (3million)
Day1,3,5 of each 28 day TMZ:150 mg/m^2 daily on Days 2-6 of each 28 day study
cycle and 200 mg/m^2 daily of subsequent cycles Drug: Temozolomide dosed at 200
mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated
every 28 days

Other Names:

• Temodar Drug: α-IFN 3mIU (3million) D1,3,5

Other Names:

Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No

Criteria: Inclusion Criteria:

- Age: 18 years to 75 years

- complete remission patients of newly diagnosed WHO III-IV glioma following standard
treatment

- Karnofsky Performance Score ≥ 60

- Adequate bone marrow, liver and renal function

- Ability of subject to understand character and individual consequences of the clinical
trial

- Written informed consent

- anticipating survival ≥2 months

Exclusion Criteria:

- Refusal to participate the study

- Known hypersensitivity or contraindication to temozolomide

- Incompletely radiation

- Pregnant or lactating females

- Malignant tumor other than brain tumor

- Contraindicated for MRI examination

- Unable to comply with the follow-up studies of this trial

- Purulent and chronic infected wounds

- Uncontrolled psychotic disorders or epilepsy

- progression disease