A study to evaluate the safety and efficacy of ex vivo expanded autologous gamma/delta T cell infusion following zoledronic acid sensitization in patients who received radiotherapy for bone metastases.

UMIN ID: UMIN000000628

Registered date:05/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with bone metastatic cancer
• Date of first enrollment: 2007/02/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gammadelta T cell Radiation Zoledronate

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Antitumor effects on the metastatic foci and primary lesion; Time to progression; Improvement of tumor-related markers, and immunological parameters.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who have: out-of-controlled infections, active autoimmune diseases, serious complications, other cancers, active enteritis, and symptoms of fibroid lung or interstitial pneumonia; who have received continuous systemic steroids; who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study

Related Information

• Primary Sponsor: University of Tokyo, Graduate School of Medicine
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology,Medinet Co.,Ltd.