advanced/recurrent ovarian cancer with the conditions of unremoval by surgery, or refractory, chemo-resistant disease.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Unresectable advanced/recurrent ovarian cancer(OVC) patient with prior chemotherapy including standard chemotherapy for OVC, and who are identified as chemoresistent and/or further chemotherapy would not continue due to their adverse events (AEs) is eligible. 2. Performance Status (PS) 0-2 3. Age:20-80 years old, in principle 4. patients with measurable/detectable disease using CT/MRI/PET-CT would be favorable(The existence of targeted lesion using RECIST version 1.01 would be more favorble). Patients who were diagnosed recurrence by clinical symptomes( acetic fluid, pleural effusion, and non-targeted disease by RECIST v.1.01 like small lesions were allowed) and marker-recurrence diagnosed by tumor markers like CA125. 5.The treatment interval from the latest prior therapy must be more than 28days. 6. Prospective survival would be 3months or over. 7. Organ functions (stated bellow) must be reserved: bone marrow function (WBC conts:2000-1,0000/mm3, Platelet: over 50,000/mm3,GOT(AST) and GPT(ALT): less than </=150IU/L, T-Bil:</=3.0mg/dL, Crn</=3.0mg/dL 8.HLA-A*0201 is positive 9. written informed consent is necessary
Exclusion criteria
Exclusion criteria: 1. pregnant women 2. breast feeding mothor(stop brest feeding) 3.women who are willing to be pregnant(must perform contraception) 4.complication of uncontrolable infection 5.Usage of continual systemic steroid and immuno-suppressant is prohibited during treatment. 6. Who are recognized ineligible by the resiponsible investigator or investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progression, evaluation of QOL, immunological evaluation, response rate | — |
Countries
Japan
Contacts
Iwate Medical University School of Medicine Department of obstetrics and gynecology Gynecologic Oncology