Therapy-resistant esophageal cancer
Conditions
Interventions
three patinets 1.Cyclophosphamide 400mg/m*2 x3days IV 2.TCR-gene-transduced autologous lymphocytes infusion 1x10*9 cells, single dose, IV
Second cohort
three patinets 1.Cyclophosphamide 400mg/m*2 x3days IV 2.TCR-gene-transduced autologous lymphocytes infusion 5x10*9 cells, single dose
Third cohort
three patinets 1.Cyclophosphamide 500mg/m*2 x3days IV 2.TCR-gene-transduced autologous lymphocytes infusion 5x10*9 cells, single dose
Fourth cohort
three patinets 1.Cyclophosphamide 600mg/m*2 x3days IV 2.TCR-gene-transduced autologous lymphocytes infusion 5x10*9 cells, single dose
Sponsors
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
TAKARA BIO INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically-confirmed malignant esophageal tumor 2.Therapy-resistant cancer, including chemotherapy and radiotherapy, with clinical stage III or IV, recurrent, and metastatic disease 3.HLA-A2402-positive 4.PCR or immunohistochemistry-confirmed MAGE-A4-antigen expression of tumor cells 5.Having measurable tumor for assessing clinical responses 6.Performance status(ECOG) 0 to 1] 7.Aged 20 to 75 years 8.Recovery lasting after the previous therapy, including surgery, chemotherapy and radiotherapy 9.At least four-month life expectancy 10.Normal major organ function, and meeting the criteria below # White cell counts 3,000/uL or more # Neutrophils 1,500/uL or more # Hemoglobin 8.0 g/dL or more # Platelets 100,000/uL or more. # Serum total bilirubin 2.0mg/dL or less # AST(GOT)/ALT(GPT) 150IU/dL or less # Serum creatinine 2.0mg/dL or less # Aterial oxygen pressure 70 torr or more, or oxygen saturation 94% or more 11.Having written informed consent
Exclusion criteria
Exclusion criteria: 1.Having following serious complications # Uncontrolled anigina pectoris, myocardial infarction, or heart failure # Uncontrolled diabetes mellitus or hytertention # Uncontrolled infection # X-ray-proven interstitial pneumonia or pulmonary fibrosis # Autoimmune disease # Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL Thrombosis tendency 2.History of serious hypersensitivity 3.Positive for HBs Ag, HCV Ab, HIV Ab, or HTLV-I Ab 4. Unctrolled pleural effusion, ascites, or pericardial effusion 5.Uncontrolled CNS metastasis 6.Systemic corticostoroid or immuno-suppressive therapy 7.Probable occurence of severe side-effects induced by cyclophosphamide 8.Mental illness or drug dependency affecting informed consent 9.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm 10. Lasting less than four weeks from the previous enrollment to clinical trials 11.Inappropriate for study entry judged by an attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| # Safety; adverse events, including laboratory data and replication competent retrovirus(RCR)/linear amplification mediated-PCR(LAM-PCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| # Kinetics and tumor infiltration of TCR/gene-transduced lymphocytes # Tumor-specific immune responses # Tumor shrinkage | — |
Countries
Japan
Contacts
Public ContactShinichi Kageyama
Mie University Graduate School of Medicine Department of Immuno-Gene Therapy
Outcome results
None listed