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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Chinese Academy of Medical Sciences; Fudan University; Tianjin Medical University Cancer Institute and Hospital; West China Hospital
• Treatments: Dacarbazine; Interferon-alpha; Interferons; Temozolomide

Criteria

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