Adoptive transfer of autologous T cells followed by vaccination with MAGE-A4-derived peptides after chemotherapy for MAGE-A4-expressing advanced cancer patients

UMIN ID: UMIN000001063

Registered date:04/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Head and neck cancer, Ovarian cancer, Esophageal cancer, Multiple myeloma
• Date of first enrollment: 2008/03/03
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Chemotherapy, three cycles cisplatinum/5FU for head/neck and esophageal cancers paclitaxel/carboplatin for ovarian cancera vincristine/doxorubicin/dexamethazone for multiple myeloma
Intravenous transfer of autologous T cells after the second and third cycle of chemotherapy. Dose-escalation study with three groups 1x10*9 cells 3 patients 3x10*9 cells 3 patients 9x10*9 cells 3 patients
Subcutaneous MAGE-A4 peptide injection, after T cell transfer sigle dose of 300microgrms

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Antigen-specific immune responses

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Positive either for HIV, HBV, HCV or HTLV-1 2)Allergic for agents used in this study, or prior allergic reactions requiring treatments 3)Notable fluid retention, including pleural effusion, ascites, or pericardial effusion. 4)Brain metastasis manifesting clinical signs and symptoms 5)Active infection 6)Unstable angina pectoris, history of myocardial infarction less than six months prior, or serious arrhythmia requiring treatments. 7)Interstitional pneumonia or pulmonary fibrosis 8)History of widespread bone marrow irradiation. 9)Paralysis or obstruction of gastrointestinal tracts. 10)Active double cancers occurring within five years, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 11)Uncontrolled diabetes mellitus 12)Women who are pregnant, milking , possibly pregnant, or refuse anticonception. 13)Judged as inappropriate for the study entry by the principle investigator or physicians responsible for the study.

Related Information

• Primary Sponsor: Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
• Secondary Sponsor: Department of Surgery, Kitano Hospital Department of Gastroenterology, Kyoto Prefectural University of Medicine
• Source(s) of Monetary Support: Department of Immuno-gene Therapy, Mie University Graduate School of Medicine Takara Bio