Ovarian cancer
Conditions
Interventions
The single injection of HiDCV-OS1 and 3 times subsequent injection of GEN010 will be done in the 10 days. This procedure is set as 1 cycle. In the first 10 days, four times administration of drugs w
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Primary registration 1) Patients providing a written informed consent to participate in this clinical study by voluntary agreement based on his will. 2) Patients proving a written informed consent to use ovarian cancer tissue obtained by operation etc. for making the fusion cell. 3) Age over 20 and less than or equal to 80 years old at the time of informed consent. 4) Have a diagnosis of ovarian carcinoma as confirmed by histology. 5) Clinical stage III or IV by FIGO2014. 6) No medical history of chemotherapy against ovarian cancer, and plant to have chemotherapy in the near future. 7) ECOG Performance Status 0 or 1. 8) The marrow, the liver or the kidney does not have serious disfunctions. Secondary registration 1) Patients providing a written informed consent to have the HiDCV-OS1 Hybrid cell therapy by voluntary agreement based on his will. 2) Prepared HiDCV-OS-1 hybrid cells compatible with appropriateness criteria. 3) Patients treated surgically for primary or metastatic lesion of ovarian cancer before or after the primary registration. 4) Patients treated with chemotherapy less than or equal to three regimens including the platinum drugs before the secondary registration, and following (1) or (2). (1)Evaluated PD after previous chemotherapy. Evaluated SD, and medical doctor diagnosed that chemotherapy was difficult to continue due to severe adverse events. Or Evaluated SD, and medical doctor diagnosed chemotherapy had no effect because of tumor progression. (2) Patients had relapsed ovarian cancer recognized by imaging test within 6 months after chemotherapy. 5) The marrow, the liver or the kidney does not have serious disfunctions. 6) ECOG Performance Status <= 2.
Exclusion criteria
Exclusion criteria: Primary registration 1) Brain metastasis 2) Serious complications such as uncontrolled active infection 3) Medical history of other malignancy, except for the relapse-free and metastasis-free for more than 2 years after the last treatment at the registration 4) Active autoimmune disease 5) Receiving systemic administration of glucocorticosteroid which restrains immunity response except low dose of oral predonisone. 6) PT(%) less than 63% or APTT more than 58.5 sec at the screening visit 7) Positive result of the HCV antibody, HBV, HIV, or HTLV-I test at the screening visit 8) Inappropriate to be enrolled in this study judged by the investigators Secondary registration 1) Withdraw the agreement after the primary registration. 2) Positive for skin prick test of GEN0101. 3) Brain metastasis. 4) Other malignancy after the primary registration. 5) Serious complications such as uncontrolled active infection. 6) Receiving systemic administration of glucocorticosteroid which restrains immunity response except low dose of oral predonisone. 7) PT(%) less than 63% or APTT more than 58.5 sec at the screening visit. 8) Administered with unapproved drug within 4 weeks before the secondary registration. 9) Inappropriate to be enrolled in this study judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events during the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Responsibility Induction of antitumor immunity Tumor marker Adverse events due to apheresis. Blood level of anti-HVJ-E antibody, and antinuclear antibody | — |
Countries
Japan
Contacts
Public ContactKenjiro Sawada
Osaka University Graduate School of Medicine Department of Obstetrics and Gynecology
Outcome results
None listed