Phase I/II clinical trial of inactivated HVJ-E administration for advanced malignant melanoma patients

UMIN ID: UMIN000002376

Registered date:26/08/2009

Basic Information

• Health condition(s) or Problem(s) studied: advanced malignant melanoma
• Date of first enrollment: 2009/07/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): HVJ-E solution

Outcome(s)

• Primary Outcome: Assessing the safety and tolerability of inactivated HVJ-E
• Secondary Outcome: Assessing the antitumor immunity and validity of inactivated HVJ-E

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1) The patient has multiple brain metastases. 2) The patient shows positive immune response by HVJ-E prick test at screening. 3) The patient has a uncontrolled serious complication such as active infection. 4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks). 5) Participation in another clinical trial of another investigational medical product within 4 weeks. 6) History of a second independent malignancy within 2 years. 7) History of active autoimmune disease 8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisone over 6 months. 9) The patient is a pregnant or lactating female. 10) Clinically relevant psychiatric disorders/ legal incapacity or a limited legal capacity. 11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue. 12) Females with childbearing potential must have a positive b-HCG pregnancy test at screening. 13) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.

Related Information

• Primary Sponsor: Department of Dermatology Osaka University Graduate School of Medicine
• Secondary Sponsor: Institute for Advanced Medical Research Keio University School of Medicine
• Source(s) of Monetary Support: none