A single-center open-label parallel-group study on the efficacy and the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.
- Conditions
- advanced or recurrent digestive organ cancer
- Registration Number
- JPRN-UMIN000008611
- Lead Sponsor
- Sapporo medical university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.