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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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11 March 2019 |
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Main ID: |
KCT0000101 |
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Date of registration:
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2011-03-02 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase III study on the efficacy and safety of CreaVax-RCC Inj. (Autologous Mature Dendritic Cells) versus Sorafenib tosylate in patients with metastatic renal cell carcinoma.
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Scientific title:
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An open, Randomized, Multi-centered Phase III study on the efficacy and safety of CreaVax-RCC Inj. (Autologous Mature Dendritic Cells) versus Sorafenib tosylate in patients with metastatic renal cell carcinoma. |
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Date of first enrolment:
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2008-06-09 |
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Target sample size:
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54 |
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Recruitment status: |
Recruiting |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1207 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT
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Phase:
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Phase3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Hyun Moo
Lee |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center |
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Name:
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Min Kyu
Heo |
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Address:
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Telephone:
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Email:
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Affiliation:
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JW CreaGene |
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
18(Year)
Age maximum:
No Limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Intervention(s)
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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 dose: CreaVax-RCC Inj 5 X 10^7Cell/injection
2. Sorafenib
be treated with 400mg oral sorafenib twice a day
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Primary Outcome(s)
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Overall survival Response rate(CR+PR)
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Secondary Outcome(s)
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Adverse event
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cell proliferation response
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correlation of immune suppression agent's concentration and immune response induction
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physical examination
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response rate
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Suppression effect of tumor progression(CR+PR+SD)
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Vital sign
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laboratory test
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Progression Free Survival
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Source(s) of Monetary Support
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JW CreaGene
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Ethics review
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Status: Submitted approval
Approval date:
Contact:
Samsung Medical center Institutional Review Board, Asan medical center Institutional Review Board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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