breast cancer, non-small cell lung cancer
Conditions
Interventions
subcutaneous injection of CHP-HER2-pulsed dendritic cells each cell dose, 0.3x10E7, 1x10E7, 3x10E7 four doses every two weeks three subjects for each cell dose, dose-escalating study
Sponsors
Hokkaido University Hospital, Kyushu University Hospital at Beppu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Either of breast cancer or non-small cell lung cancer patients, who have standard-therapy-refractory disease with unrescteable stage III, IV or metastatic lesions. Performanec status 0 to 2. Aged 20 to 75. Four weeks apart from the previous therapy, including surgery, chemotherapy, radiation therapy, heat therapy and other immuno-therapy. Life expectancy of three month or longer. preserved bone marrow, liver, kidney functions. HER2-expression of 2+ and 3+. Not having uncontrolled cardiac disease. Not having interstial pneumonia. Not having uncontrolled diabetes mellitus. Not having auto-immune disease. Having informed consent.
Exclusion criteria
Exclusion criteria: Pregnancy, contra-ceptive during trial entry. Milking. Serious bleeding tendency. Risk of thrombosis. Acitive infection, HIV, HCV and HBV-positives. Serious pleural effusion, ascites and pericardial effusion. Probable alternative drug treatment during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effect profiles, including events, frequency and grades. | — |
Secondary
| Measure | Time frame |
|---|---|
| HER2-specific immune responses anti-tumor effects | — |
Countries
Japan
Contacts
Public ContactMasaki Miyamoto1), Fumiaki Tanaka2)
Hokkaido University Hospital1), Kyushu University Beppu Medical Center2) Department of Surgery1,2)
Outcome results
None listed