CHP-MAGE-A4 vaccine study for patients with advanced lung cancer

UMIN ID: UMIN000001680

Registered date:01/03/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: MAGE-A4-expressing therapy-resistant lung cancer
• Date of first enrollment: 2009/02/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram,every week, repeated at least six cycles
Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 300 microgram,every week, repeated at least six cycles

Outcome(s)

• Primary Outcome: Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events. Efficacy: MAGE-A4-specific immune responses
• Secondary Outcome: Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.HIV-positives. 2.Double cancers. 3.Autoimmune disease. 4.History of serious hypersensitivity. 5.Active CNS metastasis. 6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors 7.Pregnant or lactating. 8.Inappropriate for study entry judged by an attending physician.

Related Information

• Primary Sponsor: CHP-MAGE-A4 cancer vaccine study at University of Occupational and Environmental Health, Japan
• Secondary Sponsor: Cancer vaccine, Mie University
• Source(s) of Monetary Support: University of Occupational and Environmental Health, Japan