Unique ID issued by UMIN | UMIN000010840 |
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Receipt number | R000012688 |
Scientific Title | Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients ' |
Date of disclosure of the study information | 2013/06/01 |
Last modified on | 2013/05/30 13:04:59 |
Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients '
Subsequent injection of HVJ-E
Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients '
Subsequent injection of HVJ-E
Japan |
castration resistant prostate cancer
Urology |
Malignancy
NO
The objective of this study is to evaluate safety, induction of tumor immunity, and anti-tumor effect of subsequent injection of HVJ-E to those patients who enrolled in the previous HVJ-E clinical trail.
Safety
Confirmatory
Explanatory
Phase I,II
To assess safety and tolerability of HVJ-E
1. To evaluate induction of tumor immunity
2. To evaluate anti-tumor effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
HVJ-E solution
20 | years-old | <= |
90 | years-old | > |
Male
1. The patient who enrolled in the "Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous infection of HVJ-E to castration resistant prostate cancer patients" and completed the protocol of this trial.
2. The patient who has provided a written informed consent prior to any study-related procedure.
3. The patient who is not a candidate of standard docetaxel chemotherapy/ refractory to standard docetaxel chemotherapy according to criteria of The Prostate Cancer Clinical Trials Working Group (PCWG2), or deny to receive standard docetaxel chemotherapy.
4. The patient who has PSA value less than 100ng/ml
5. The patient who has a life expectancy for at least 12 weeks or more.
6. The patient who has a ECOG Performance Status Scale of 0 or 1.
7. The patient who has the organs function adequately evaluated by the following lab values;
WBC: equal or more than 2,000/microL
PLT: equal or more than 75,000/microL
Hemoglobin: equal or more than 8.0g/dL
GOT: equal or less than 100IU/L
GPT: equal or less than 100IU/L
T-bil: equal or less than 2.5mg/dL
Serum creatinine: equal or less than 2.3mg/dL
1. The patient who was 'progressive disease (PD)' assessed by PSA value in the "Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous infection of HVJ-E to castration resistant prostate cancer patients."
2. The patient who has brain metastases.
3. The patient who shows positive immune response by HVJ-E prick test at screening.
4. The patient who has a uncontrolled serious complication such as active infection.
5. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks.
6. The patient who has any active autoimmune diseases.
7. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months.
8. The patient who is undergoing on immunosuppressive agents.
9. The patient who has a history of a transplantation of the allogeneic organ.
10. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range.
11. The patient who is inappropriate to be enrolled in this trial judged by the doctors in charge.
9
1st name | |
Middle name | |
Last name | Norio Nonomura |
Osaka University Graduate School of Medicine
Department of Urology
2-2 Yamadaoka, Suita, Osaka, Japan
1st name | |
Middle name | |
Last name | Yasutomo Nakai |
Osaka University Graduate School of Medicine
Department of Urology
nakai@uro.med.osaka-u.ac.jp
Department of Urology, Osaka University Graduate School of Medicine
Ministry of Education, Culture, Sports, Science and Technology
NO
2013 | Year | 06 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 05 | Month | 28 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 05 | Month | 30 | Day |
2013 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012688
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