Head and neck cancer, Ovarian cancer, Esophageal cancer, Multiple myeloma
Conditions
Interventions
Chemotherapy, three cycles cisplatinum/5FU for head/neck and esophageal cancers paclitaxel/carboplatin for ovarian cancera vincristine/doxorubicin/dexamethazone for multiple myeloma
Intravenous
Sponsors
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Department of Surgery, Kitano Hospital Department of Gastroenterology, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Either of the following disease a)Epidermal ovarian carcinoma with recurrence or residual disease after standard treatment or unresectable recurrence, being planned to receive at least three cycles of TJ(Taxol/Carboplatin) therapy. b)Head and neck squamous cell carcinoma with recurrence not having curative treatment options, residual disease after standard therapy, or patients refusal of surgical treatment, being planned to receive at least three cycles of chemotherapy. c)Esophageal carinoma with recurrence after standard therapy or primary unmanageable disease. d)Multiple myeloma with recurrence or primary therapy-resistance. 2)Positive for MAGE-A4 antigen and at least one of NY-ESO-1, WT-1, MAGE-A3 and SAGE antigens on tumor cells. 3)Positive HLA-type for A2402 or A0201. 4)Aged from 20 to 75 years. 5)Grade 0 to 2 in performance status(ECOG). 6)Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous anti-metabolites. 7)No major organ dysfunctions, including bone marrow, heart, lung, liver, and kidney, which meet the following criteria For head/neck, esophageal and ovarian cancers WBC 3,000/mm3 or more Neutrophils 1,500/mm3 or more Platelets 10x103/mm3 or more Hb 9.0/dL or more AST(GOT), ALT(GPT) 100 IU/L or less Total bilirubin 2.0 mg/dL or less Serum creatinine 1.5 mg/dL or less For multiple myeloma AST(GOT), ALT(GPT) within three times of normal upper range Total bilirubin 2.0 mg/dL or less Serum creatinine within three times of normal upper range 8) Having tolerable function of bone marrow, liver and kidneys for chemotherapy being used in the study. 9) Able to be followed with safety and immune response profiles throughout the study. 10) Expected to be alive at least three months after informed consent. 11) Full understanding of the study and voluntary agreement with written informed consent.
Exclusion criteria
Exclusion criteria: 1)Positive either for HIV, HBV, HCV or HTLV-1 2)Allergic for agents used in this study, or prior allergic reactions requiring treatments 3)Notable fluid retention, including pleural effusion, ascites, or pericardial effusion. 4)Brain metastasis manifesting clinical signs and symptoms 5)Active infection 6)Unstable angina pectoris, history of myocardial infarction less than six months prior, or serious arrhythmia requiring treatments. 7)Interstitional pneumonia or pulmonary fibrosis 8)History of widespread bone marrow irradiation. 9)Paralysis or obstruction of gastrointestinal tracts. 10)Active double cancers occurring within five years, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 11)Uncontrolled diabetes mellitus 12)Women who are pregnant, milking , possibly pregnant, or refuse anticonception. 13)Judged as inappropriate for the study entry by the principle investigator or physicians responsible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Antigen-specific immune responses | — |
Countries
Japan
Contacts
Public ContactShinichi Kageyama
Mie University Graduate School of Medicine Department of Immuno-Gene Therapy
Outcome results
None listed