It HLA-restricted, tumor specific cytotoxic responses by in vitro stimulations. In this study, we conducted

May 29, 2018

It HLA-restricted, tumor specific cytotoxic responses by in vitro stimulations. In this study, we conducted a phase I pilot trial of vaccination of a SYTSSX-derived junction peptide in elected synovial sarcoma patients.Systems (San Diego, CA). The identity of the peptide was confirmed by mass spectral analysis, and was shown to have more than 98 purity when assessed by high pressure liquid chromatography analysis. The peptide was delivered us in the form of a freeze-dried, sterile white powder. It was dissolved in 1.0 ml of physiological saline (Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan) and stored at -80 until just before usage. The affinity of the peptide to HLA-A24 molecules and its antigenicity were determined in previous studies[13,14].Eligibility The study protocol was approved by the Clinical Institutional Ethical Review Board of the Medical Institute of Bioregulation, Sapporo Medical University, Japan. Eligible patients were those (i) who have histologically and genetically confirmed, unresectable synovial sarcoma (SYT-SSX1 or SYT-SSX2 positive), (ii) HLA-A*2402 positive, (iii) between 20 and 70 years old, (iv) ECOG performance status between 0 and 3, and (v) who gave informed consent. Exclusion criteria included (i) prior chemotherapy, steroid therapy, or other immunotherapy within the past 4 weeks, (ii) presence of other cancers that might influence the prognosis, (iii) immunodeficiency or a history of splenectomy, (iv) severe cardiac insufficiency, acute infection, or hematopoietic failure, (v) ongoing breast-feeding, (vi) unsuitability for the trial based on the clinical judgment of the doctors involved. This study was carried out at the Department of Orthopaedic Surgery, Sapporo Medical University Hospital from June 2003 until the end of September 2004. Vaccination schedule Vaccinations with SYT-SSX B peptide were administered subcutaneously into the upper arm six times at 14-day intervals. In order to set up a dose-escalation trial, the patients were separated into the two groups. Each group included three patients. Those from group 1 received 0.1 mg and group 2 participants received 1.0 mg. Delayed-type hypersensitivity (DTH) skin test Delayed-type hypersensitivity (DTH) skin test was performed at each vaccination. The peptide (10 ) solution in physiological saline (0.1 ml) or PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/25447644 physiological salinePage 2 of(page number not for citation purposes)MethodsPeptide A 9-mer peptide (SYT-SSX B: GYDQIMPKK) spanning the SYT-SSX fusion region was synthesized under good manufacturing practice (GMP) conditions by Multiple PeptideJournal of Translational Medicine 2005, 3:http://www.translational-medicine.com/content/3/1/alone (0.1 ml) were separately injected intradermally into the forearm. A LY317615 price positive reaction was defined as a diameter of erythema of more than 4 mm, 48 hr after the injection.Toxicity evaluation Patients were examined closely for signs of toxicity during and after vaccination. Adverse events were recorded using the National Cancer Institute Common Toxicity Criteria (NCI-CTC). Clinical response evaluation Physical examinations and hematological examinations were monitored before and after each vaccination. Tumor size was evaluated by computed tomography (CT) scans before treatment, and again after three vaccinations, and then at the end of the study period. A complete response (CR) was defined as complete disappearance of all measurable diseases. A partial response (PR) was defined as a >= 50 decrease from the bas.