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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Glioblastoma; Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma

Treatments: Drug: β-elemene

Study type: Interventional

Funder types: Other

Identifiers

NCT02629757

CSNO2015001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

β-elemene

Experimental group

Description:

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

Treatment:

Drug: β-elemene