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

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.

Conditions

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Anaplastic Oligoastrocytoma Anaplastic Astrocytoma Glioblastoma

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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β-elemene

β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.

Group Type EXPERIMENTAL

β-elemene

Intervention Type DRUG

β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles

Interventions

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β-elemene

β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No