Unique ID issued by UMIN | UMIN000002136 |
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Receipt number | R000002608 |
Scientific Title | Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma |
Date of disclosure of the study information | 2009/07/02 |
Last modified on | 2016/01/29 13:36:58 |
Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma
Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma
Japan |
Renal cell carcinoma
Urology |
Malignancy
NO
To investigate safety and efficacy on combination therapy of autologous tumor lysate- pulsed dendritic cell vaccination and sunitinib for advanced renal cell carcinoma.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Safety
Immunological responses
Antitumor effect
Overall survival
Progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine | Maneuver |
Tumor lysate-pulsed dendritic cell
Sunitinib
20 | years-old | <= |
Not applicable |
Male and Female
Renal cell carcinoma patients who undergo surgical resection of primary lesion and receive sunitinib for metastatic lesion:
- Pathological diagnosis of renal cell carcinoma;
- Tumor tissue is preserved after resection of primary lesion and tumor lysate is aseptically prepared;
- Measurable lesion;
- 20 years or more;
- Performance status is 0-2;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them;
- Serious drug allergy;
- Active infections;
- Serious cardiac disease;
- Active autoimmune diseases;
- Continuous systemic administration of steroids within 4 weeks;
- Other cancers.
15
1st name | |
Middle name | |
Last name | Yukio Homma |
The University of Tokyo Hospital
Department of Urology
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
03-5800-8662
1st name | |
Middle name | |
Last name | Kazuhiro Kakimi |
Graduate School of Medicine, The University of Tokyo
Department of Immunotherapeutics
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
03-5805-3161
immunotherapy-admin@umin.ac.jp
The University of Tokyo Hospital
Medinet Co.,Ltd.
Profit organization
Japan
NO
2009 | Year | 07 | Month | 02 | Day |
Partially published
Journal for ImmunoTherapy of Cancer.2014,2:30
Completed
2009 | Year | 01 | Month | 15 | Day |
2009 | Year | 07 | Month | 01 | Day |
2015 | Year | 01 | Month | 31 | Day |
2009 | Year | 06 | Month | 29 | Day |
2016 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002608
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