UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011028
Receipt number 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 11:03:44

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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
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