Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers

UMIN ID: UMIN000001081

Registered date:16/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
• Date of first enrollment: 2006/05/01
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CHP-HER2 vaccine 300micrograms CHP-NY-ESO-1 vaccine 100micrograms OK-432 0.02mg SQ injection, q2wks, 6 cycles

Outcome(s)

• Primary Outcome: 1.Safety of CHP-HER2 and CHP-NY-ESO-1 administered subcutaneously in combination with OK-432 to patients with cancers expressing HER2 and/or NY-ESO-1. 2.Immunity to HER2 and NY-ESO-1 (antibody, CD4+ and CD8+ T cells)
• Secondary Outcome: Tumor responses

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Clinically significant heart disease (NYHA Class III or IV). 2.Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram. 3.Immunodeficiency disease. 4.Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders. 5.Previous bone marrow or stem cell transplant. 6.Metastatic disease to the central nervous system, unless treated and stable. known HIV antibody positivity. 7.Anaphylactic reaction to previous vaccination. 8.Hypersensitivity to penicillin Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). 9.Concomitant treatment with steroids. Topical or inhalational steroids are permitted. 10.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. Pregnancy or nursing . 11.Refusal, by women of childbearing potential, to use medically acceptable means of contraception. 12.Mental impairment that may compromise the ability to give informed consent. 13.Lack of availability for immunological and clinical follow-up assessment.

Related Information

• Primary Sponsor: Mie University Graduate School of Medicine, Kitano Hospital
• Secondary Sponsor: Ludwig Institute for Cancer Research
• Source(s) of Monetary Support: Mie University Graduate School of Medicine
• Secondary ID(s): NCT00291473