None listed
Conditions
Interventions
Biological/Vaccine : 1. CreaVax-RCC Inj.
primary vaccination
after two weeks interval, 4 times
wash out: during 6 weeks
second vaccination (boosting)
after two weeks interval, 2 times
vaccination dos
Sponsors
Creagene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient have diagosed with metastatic renal cell carcinoma,have measurable metastatic lesion and agree to have Nephrectomy. 2. Age=18 years old / both male and female 3. A patient with ECOG scale(ECOG-PS) 0-2 4. A patient over 6 months survival expected 5. Hemoglobin= 9g/dL, WBC = 4,000/mm3, Platelet = 100,000/ mm3 6. PT(INR)<1.5, aPTT<1.5 X ULN 7. Creatinine= 2.0 mg/dL 8. Bilirubin = 2.0 mg/dL, AST/ALT = 100 IU/L 9. anti-nuclear antibody, anti-thyroglobulin antibody negative 10.A patient represent DTH positive about PPD(recall antigen) 11.A patient had not surgery, radiotherapy, hormone therapy, immune therapy or chemical therapy before screening for more than 4 weeks. In addition, patients have recovered from side effects. 12.A patient agreed to contracept during clinical study 13.A patient participates in the clinical trial voluntarily signing up.
Exclusion criteria
Exclusion criteria: 1. A patient with another cancer or the history of cancer. 2. A patient with brain metastases 3. A patient with the medical history of autoimmune disease 4. A patient have a infectious disease needed to inject a parenteral antibiotic treatment. 5. A HBsAg, Anti-HCV, HIV positive patient 6. Patients is with myocardial infarction, congestive heart failure, serious cardiac disorder or unregulating high blood pressure. 7. A patient with obstructive, restrictive lung disease 8. Blood calcium level of patient is over 10.5mg/dL or having hypercalcemia 9. A patient with serious an internal disease 10.A patient have a hypersensitivity about Sorafenib or autologous cell vaccine 11.Pregnant woman, nursing woman 12.A patient with the medical history of psychological disease or epilepsy 13.A patient who has participated in another clinical trial within the last 4 weeks of the start of study 14.Patient is judged by the P.I as the patient is not suitable for the research. 1. Patients who have received the administration of an steroid, cyclosporin A or azathiopurine=4 weeks prior to starting study treatment 1. Adequate tumor cells weren't stored and unavailable to produce for a minimum of vaccine preparations. 2. Adequate PBMCs from leukapheresis weren't stored and unavailable to produce for a minimum of vaccine preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Response rate(CR+PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Suppression effect of tumor progression(CR+PR+SD);response rate;cell proliferation response;correlation of immune suppression agent's concentration and immune response induction;Adverse event;Vital sign;physical examination;laboratory test | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Kyu Heo
JW CreaGene
Outcome results
None listed