advanced or recurrent digestive organ cancer
Conditions
Interventions
SVN-2B vaccine is injected under the skin at a dose of 0.3 mg/body combined with montanide ISA 51VG 1ml, once every two weeks. The treatment regimen is 4 doses.
SVN-2B vaccine is injected under the sk
Sponsors
Sapporo medical university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients must have been given a definitive diagnosis of gastrointestinal carcinoma. (2) In each patient it must be confirmed that survivin protein was expressed in cancer cells. (3) Patients must meet 1 and 2 or 1 and 3 of the following criteria. 1) Inoperable status, with distant metastasis or recurrence. 2) Patients who will be administrate their first treatment because no standard chemotherapy was either advisable or available. 3) Did not respond sufficiently to the standard chemotherapy or could not tolerate the treatment. (4) Have measurable lesion as determined by CT or MRI during the previous observation period. (5) Patients must be HLA-A*2402 positive. (6) Patients who have 1.6 or less log10 (1+CTLpre): CTLpre, the number of SVN-2B peputide-specific CTL in the previous observation period (the number of SVN-2B tetramer-positive CTL over 10,000 CD8-positive T cells by the tetramer analysis). (7) Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. (8) Patients who have been confirmed as having no serious organ failure within 30 days precious to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75*103/uL, 1.5 times serum creatinine level <= normal upper limit level, a total serum bilirubin level <= normal upper limit level, AST and ALT <=2 times normal upper limit level). (9) Patients must be 20-85 years of age at the time of agreement. (10) Patients must receive substantial and sufficient explanation of the content of this trial in all its aspects and provide.
Exclusion criteria
Exclusion criteria: (1) Patients with an infection and who need systemic therapy such as antibiotics or antiviral medication. (2) Patients who are positive in any test for HBV, HCV and HIV within 90 days before registration. (3) Patients with any disorder that might preclude participation in the protocol, such as a history of severe heart failure, myocadinal infarction within 180 days before registration, arrhythmia requiring medical treatment, and those with severe obstructive lung disease. (4) Patients with diabetes that cannot be controlled or those with hypertension. (5) Patients with pleural effusion requiring drainage, pericardial fluid or ascites. (Patients who have had their drainage removed at least 14 days and who might be expected to participate safely, in this study, can be eligible.) (6) Patients with brain metastatic disease and who have displayed any cranial nerve symptoms. (7) Patients with any other life-threatening disease. (8) Patients who cannot be evaluated adequately during the clinical course. (9) Patients who have received SVN-2B in the past. (10) Patients who are under treatment as described below itmes. 1) Surgery or radiotherapy. 2) Chemotherapy (including molecular targeted medicine). 3) Nitrosourea or MMC. 4) Endocrine therapy or immunotherapy (including the BRM therapy). 5) Blood transfusion,or hemopoietic factor. 6) Administration of immunosuppressive drug. 7) Other investigational new drugs or unlicensed drugs. (11) Patients who are required to be administered steroids. (12) Patients who have suffered from any side effect of a severity greater than Grade 2, as prescribed in CTCAE ver.4.03. (13) Patients with a history of a serious drug allergy in the past. (14) Pregnant women or those who are lactating. (15) Patients who are determined as being an inappropriate study case by the trial responsibility physicians or trial allotment physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is safety: Then first we observe for adverse effects. Second, laboratory data, vital signs and weight are measured, and finally a 12-lead electrocardiogram is conducted. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are immunological effects and shrinkage of cancer. Immunological effects are investigated as described below. SVN-2B peptide-specific CTL frequency is evaluated by tetramer analysis. SVN-2B peptide-specific CTL response is evaluated by enzyme linked immuno-sorbent spot (ELISPOT) assay. In addition, shrinkage of cancer is evaluated by CT or MRI imaging tests before vaccination and after the fourth treatment. | — |
Countries
Japan
Contacts
Public ContactToshihiko Torigoe
Sapporo medical university Department of pathology (I)
Outcome results
None listed