CHP-MAGE-A4 cancer vaccine study for refractory MAGE-A4-expressing cancer

UMIN ID: UMIN000002153

Registered date:02/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: MAGE-A4-expressing refractory cancer patients (non origin-limited) or patients who refuse standard therapy
• Date of first enrollment: 2009/07/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events Efficacy: MAGE-A4-specific immune responses
• Secondary Outcome: Efficacy: tumor responses, progression-free survival, 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 corticosteroid, immuno-suppresive or stimulating agents, radiotherapy, or operation for primary tumors 7.Pregnant or lactating 8.Inappropriate for study entry judged by an attending physician

Related Information

• Primary Sponsor: The Tazuke Kofukai Medical Research Institute
• Secondary Sponsor: Department of Cancer Vaccine Mie University Graduate School of Medicine
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research by The Ministry of Education, Culture, Sports, Science and Technology