advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma, bladder cancer.
Conditions
Interventions
NY-ESO-1 OLP (4 peptides total 1 mg)+Montanide ISA-51 (1.0 mL)+ K-432 (Picibanil) (0.2 KE) Every 2 weeks x 6 times
Sponsors
Department of Immunology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Surgery and Clinical Oncology, Osaka University Graduate School of Medicine Department of Immunotherapeutics Graduate School of Medicine The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological diagnosis of any type of cancers expressing NY-ESO-1 antigen. 2.Advanced cancer patient. 3.Performance status of 0-2. 4.Age 20-80 years. 5.At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent. 6.Life expectancy > 3 months. 7.Laboratory values within the following limits: WBC > 3000/mm3 Neutrophil count > 1500/mm3 Hemoglobin> 8.0 g/dL Platelet count > 80,000/mm3 Serum bilirubin < 2.0 mg/dl AST,ALT < 150 IU/l Serum creatmine < 2.0 mg/dL 8.Tumor with NY-ESO-1 expression 9.Able and willing to give witnessed, written informed consent for participation in the trial 10.Evaluable tumor 9.no penicillin allergy
Exclusion criteria
Exclusion criteria: 1.Clinically significant heart disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias). 2.Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders. 3.Previous bone marrow or stem cell transplant. 4.History of immunodeficiency disease or autoimmune disease except vitiligo. 5.Metastatic disease to the central nervous system, unless treated and stable. 6.Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ. 7.Known HIV, positivity. 8.Concomitant treatment with steroids. Topical or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.) 9.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent. 10.Pregnancy or lactation. 11.Women of childbearing potential not using a medically acceptable means of contraception. 12.Psychiatric or addictive disorders that may compromise the ability to give informed consent. 13.Lack of availability of the patient for immunological and clinical follow-up assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| NY-ESO-1 specific immunity will be assessed using blood. NY-ESO-1 reactive antibodies measured by ELISA and cellular immunity by NY-ESO-1 specific CD4 and CD8 T cells by cytokine secretion as determined by FACS analysis will be assayed. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Disease status will be assessed at baseline and 2 weeks after the sixth vaccination in patients with evaluable (measurable and non-measurable) disease. | — |
Countries
Japan
Contacts
Public ContactHisashi Wada
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed