unresectable digestive cancer, lung cancer
Conditions
Interventions
Intravenous transfer of autologous T cells. Dose-escalation study with three groups 1x10*9 cells 3 patients 3x10*9 cells 3 patients 9x10*9 cells 3 patients
Sponsors
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Hyakumanben clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed digestive cancer or lung cancer. 2) Patients informed diagnosis of their disease 3) Patients must have recurrent disease after standard treatment, and in the situation where curative treatment opions are not available. 4) Patients must have residual disease after standard treatment, and in the situation where curative treatment options are not available. 5) Without planning to recieve chemotherapy, radiation therapy or BRM. Oral 5-FU drugs are permitted. 6) Aged from 20 to 80 years 7) Grade 0 to 2 in performance status(ECOG). 8) Expected to be alive at least three months after informed consent. 9) Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous administration of 5-FU. But oral 5-FU drugs are permitted. 10) Sufficient functions of major organ. 11) Having written informed consent.
Exclusion criteria
Exclusion criteria: 1) Presence of uncontrolled infection 2) Hypersensitivity or autoimmune disease requiring treatments 3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis) 4) Inappropriate patients for this study due to severe complications. 5) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 6) Medical history of severe hypersensitivity. 7) Severe mental impairment 8) Pregnant or lactating women 9) Inappropriate patients for study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate | — |
Countries
Japan
Contacts
Public ContactSatoshi Kokura
Graduate School of Medical Science, Kyoto Prefectural University of Medicine Molecular Gastroenterology and Hepatology
Outcome results
None listed