Dendritic cell-based tumor-specific immunotherapy against malignant brain tumor - Phase I clinical trial

UMIN ID: UMIN000000914

Registered date:01/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant brain tumor (malignant glioma)
• Date of first enrollment: 2007/09/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Administration of multiple peptides-treated activated dendritic cell vaccines to malignant glioma patients in a dose-escalation manner

Outcome(s)

• Primary Outcome: Safety of immunotherapy
• Secondary Outcome: Antitumor effect, Immunological effect

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Within 28 days after the last treatment against cancer 2. Severe systemic infection, hematostatic dysfunction, and organ disorder 3. Steroid treatment, except used for cerebral decompression 4. Hypersensitivity to DC vaccine 5. Severe immunological disorders (autoimmune disease, immunosuppression) 6. Multiple cancers 7. Anaphylaxis to synthetic peptides

Related Information

• Primary Sponsor: Shizuoka Cancer Center
• Source(s) of Monetary Support: Shizuoka Prefecture