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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011028
Receipt No. R000012911
Scientific Title Phase II, randomized, placebo-controlled study of docetaxel in combination with a mixed 20 peptides vaccine in patients with castration-resistant prostate cancer (CRPC)
Date of disclosure of the study information 2013/07/01
Last modified on 2015/11/17

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Basic information
Public title Phase II, randomized, placebo-controlled study of docetaxel in combination with a mixed 20 peptides vaccine in patients with castration-resistant prostate cancer (CRPC)
Acronym Phase II study of docetaxel in combination with a mixed 20 peptide vaccine in patients with CRPC
Scientific Title Phase II, randomized, placebo-controlled study of docetaxel in combination with a mixed 20 peptides vaccine in patients with castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym Phase II study of docetaxel in combination with a mixed 20 peptide vaccine in patients with CRPC
Region
Japan

Condition
Condition Castration-resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of a mixed 20 peptides vaccine (KRM-20) in combination with docetaxel in patients with CRPC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rates of serum Prostate-specific antigen (PSA) level declines of in treatment patients
Key secondary outcomes 1. Progression-free survival (RECIST and PSA response)
2. Immune response
3. 1 year Progression-free survival (RESIST and PSA response)
4. Overall survival
5. Adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Arm A:
Patients receive mixed 20 peptides vaccine (KRM-20; 20mg/0.5ml) subcutaneously (SC) on days 1, 8, 15, 22 and 29, and oral dexamethasone (1mg) once daily on days 1 - 36. Begining on day 36, patients receive docetaxel IV (70mg/m2) over 1 hour and KRM-20 SC on day 1, and oral dexamethasone daily on days 1-21. Treatment with docetaxel, KRM-20 and dexamethasone repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Interventions/Control_2 Arm B:
Patients receive placebo (0.5ml) subcutaneously (SC) on days 1, 8, 15, 22 and 29, and oral dexamethasone (1mg) once daily on days 1 - 36. Begining on day, patients receive docetaxel IV (70mg/m2) over 1 hour and placebo SC on day 1, and oral dexamethasone daily on days 1-21. Treatment with docetaxel, placebo and dexamethasone repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
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

Not applicable
Gender Male
Key inclusion criteria The subjects must satisfy the following conditions.
1. Patients must be diagnosed as prostate cancer pathologically at the initial treatment.
2.Patients who had progressive disease after androgen deprivation therapy (ADT) either by surgical castration, gonadotropin-releasing hormone or antagonist treatment.
Progression disease while receiving ADT, defined by any 1 of the following:
1) At least 2 consecutive rises in serum PSA obtained at a minimum of 1-week intervals.
2) Measurable disease with >=50% increase in the sum of the cross products of all measurable lesions, or the development of new measurable lesions by RESIST.
3) Non-measurable (bone) disease consisting of new areas of uptake by bone scan consistent with metastatic disease compared to previous imaging.
3. Patients have serum PSA level 2>= ng/mL.
4. Anti-androgen therapy is discontinued for at least 4 weeks before the first vaccination for patients receiving flutamide and 6 weeks for those receiving bicalutamide.
5. Patients continue to stay on medical treatment such as LHRH agonists of LHRH antagonists to maintain testosterone level of 0.5ng/mL.
6. Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type (A3,A11,A31,A33).
7. Written informed consent must be obtained from patients.
8. Patients must be more 20 year-old.
9. Patients must be at a score level
of 0-1 of performance status (ECOG).
10. Patients must be expected to survive more than 6 months.
11. Patients must satisfy the followings:
WBC >= 3,000/mm3
Neutrophil >= 2,000/mm3
Lymphocyte >= 1,000/mm3
Hb >= 8.0g/dl
Platelet >= 100,000/mm3
Serum Creatinine <= 2 times upper limit of normal
Total Bilirubin <= 1.5 times upper limit of normal
AST, ALT <= 2 times upper limit of normal
Key exclusion criteria The following patients must be excluded:
1. Patients who had received chemotherapy using docetaxel any time before the treatment.
2. Patients who had received pre-therapies including chemotherapy or immunotherapy within 28 days before the treatment.
3. Patients who had received radiotherapy or strontium-89 within the last 8 weeks before the treatment.
4. Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
5. Patients with active multiple cancers
6. Patients with the past history of severe allergic reactions.
7. Patients who do not agree with contraception during treatment and until 70 days after treatment.
8. Patients who had enrolled in another trial within 3 months or who are treating in another trial.
9. Patients who had received any peptides consist of a mixed 20 peptides (KRM-20).
10. Patients who are difficult to participate in this trial because of psychiatric symptoms.
11. Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Noguchi
Organization Kurume University School of Medicine
Division name Clinical Research Division of Research Center for Innovative Cancer Therapy
Zip code
Address 67 Asahi-machi, Kurume,
TEL 0942-31-7989
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University School of Medicine
Division name Cancer Vaccine Division of Research Center for Innovative Cancer Therapy
Zip code
Address 67 Asahi-machi, Kurume,
TEL 0942-31-7572
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Research Center for Innovative Cancer Therapy, Kurume University School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyushu University
Kitasato University
Dokkyo Koshigaya Hospital
Kumamoto University
Kagoshima University
Okayama University
Kinki University
Jikei University
Hirosaki University
Name of secondary funder(s) Kurume University

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW 25-0970 (PMDA)

Institutions
Institutions 1. 久留米大学医療センター(福岡県)1. Kurume University Medical Center
2. 九州大学病院(福岡県) 2. Kyushu University Hospital
3. 北里大学医学部(神奈川県) 3. Kitasato University Hospital
4. 獨協医科大学越谷病院(埼玉県)4. Dokkyo Medical University Koshigaya Hospital
5. 熊本大学病院(熊本県) 5. Kumamoto University Hospital
6. 鹿児島大学病院(鹿児島県) 6. Kagoshima University Hospital
7. 岡山大学病院(岡山県) 7. Okayama University Hospital
8. 近畿大学病院(大阪府) 8. Kinki University Hospital
9. 東京慈恵医科大学病院(東京都) 9. Jikei University Hospital
10. 弘前大学病院(青森県) 10. Hirosaki University Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 07 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 Completed
Date of protocol fixation
2013 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 24 Day
Last modified on
2015 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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