UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006142 |
|---|---|
| Receipt number | R000007153 |
| Scientific Title | 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 | 2011/09/01 |
| Last modified on | 2012/09/25 14:08:14 |
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Basic information
Public title
Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients
Acronym
Clinical study of intratumoral and subcutaneous injection of HVJ-E to CRPC patients
Scientific Title
Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients
Scientific Title:Acronym
Clinical study of intratumoral and subcutaneous injection of HVJ-E to CRPC patients
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate safety and tolerability of HVJ-E to CRPC patients. The secondary objective is to analyze tumor immunity and anti-tumor effect of HVJ-E to CRPC patinents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
To assess safety and tolerability of HVJ-E
Key secondary outcomes
1. To evaluate induction of tumor immunitiy
2. To evaluate anti-tumor effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
HVJ-E solution
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1. The patient who has provided a written informed consent prior to any study-related procedure.
2. The patient who is at least over 20 years and not exceeding 90 years.
3. The patient who has a histological or cytological diagnosis of adenocarcinoma of the prostate.
4. The patient who is castration resistant prostate cancer.
5. 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. The patient who is refractory to standard docetaxel chemotherapy cannot include to this trial until 6 weeks has passed from last administration of docetaxel.
6. The patient who has PSA value less than 100ng/ml
7. The patient who has a life expectancy for at least 12 weeks or more.
8. The patient who has a ECOG Performance Status Scale of 0 or 1.
9. The patient who has injectable lesion in the prostate which can be evaluated by MRI or CT.
10. 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
Key exclusion criteria
1. The patient who has brain metastases.
2. The patient who shows positive immune response by HVJ-E prick test at screening.
3. The patient who has a uncontrolled serious complication such as active infection.
4. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks.
5. The patient who participated in another clinical trial of another investigational medical product within 4 weeks.
6. The patient who has history of second independent malignancy within 2 years.
7. The patient who has any active autoimmune diseases.
8. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months.
9. The patient who is undergoing on immunosuppressive agents.
10. The patient who has clinically relevant psychiatric disorders/ legal incapacity or limited legal capacity.
11. The patient who has a history of a transplantation of the allogeneic organ.
12. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range.
13. The patient who in inappropriate to be enrolled in this trial judged by the doctors in charge.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nonomura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
TEL
06-6879-3531
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | RIe Sumida |
Organization
Osaka University Hospital
Division name
Medical Center for Translational Research
Zip code
Address
2-15 Yamadaoka, Suita city, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 10 | Day |
Last modified on
| 2012 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007153
