A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Glioblastoma; Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma

Treatments: Drug: Temozolomide; Drug: α-IFN

Study type: Interventional

Funder types: Other

Identifiers

NCT01765088

CSNO2012001

Details and patient eligibility

About

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

Full description

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 years to 75 years
• newly diagnosed WHO III-IV glioma after operation and radiotherapy
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

temozolomide

Active Comparator group

Description:

Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m\^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles)

Treatment:

Drug: Temozolomide

temozolomide +α-IFN

Experimental group

Description:

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

Treatment:

Drug: α-IFN

Drug: Temozolomide