UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001096 |
|---|---|
| Receipt number | R000001326 |
| Scientific Title | A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer |
| Date of disclosure of the study information | 2008/03/26 |
| Last modified on | 2010/04/05 09:22:13 |
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Basic information
Public title
A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Acronym
Randomized trial of peptide vaccination for hormone-refractory prostate cancer patients
Scientific Title
A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Scientific Title:Acronym
Randomized trial of peptide vaccination for hormone-refractory prostate cancer patients
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-tumor effect and safety of personalized peptide vaccine plus low-dose estramustine with full dose estramustine for HLA-A2 and –A24 positive patients with hormone refractory prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
1. adverse events
2. overall survival
3. Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet.
4. Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Select peptide candidates (up to 4), to which CTL precursors or peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 2 weeks interval. Start internal use of estramustine 2 cap (2X) (280 mg/day) on the same day with peptide vaccination.
After PD(Three consecutive and 125% increase from baseline PSA levels at least two weeks apart), patients are treated with B regime.
Interventions/Control_2
B: Full dose of estramustine alone (4 cap 2X, 560 mg/day)
After PD(Three consecutive and 125% increase from baseline PSA levels at least two weeks apart), patients are treated with A regime.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
The subjects must satisfy the following conditions.
1)Patients must be diagnosed as prostate cancer pathologically after the treatment of castration, LH-RH analogue therapy, anti-andorogen therapy, or female hormone therapy. The patients must be suffering from hormone refractory prostate cancer(#1,2,3,4)
#1: The measurable tumor size must be more than 2 cm by X-ray and the level of PSA must increase more than 3 times consecutively at more than 2 weeks interval.
#2: Patients must be drug-free more than 4 weeks after hormone therapies or chemotherapies. The hormone withdrawal syndrome must be ruled out.
#3: In the cases of patients without castration, the LH-RH analogue therapy will be continued to keep the level of testosterone.
#4: Patients must not receive the treatment with bisphosphonate and steroid.
2) Patients must be positive for HLA-A2 or HLA-A24.
3) Patients must have IgG reactive to at least one of peptide candidates.
4) When patients had received pre-therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started at least more than 4 weeks after the last therapy. Patients showing anti-tumor effects or adverse effects of pre-therapy must be excluded.
5) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC >= 3,000/mm3
(Lymphocyte >= 1,200/mm3)
Hb >= 9.0 g/dl
Platelet >= 100,000 /mm3
Serum Creatinine <= 1.4 mg/dl
Total Bilirubin <= 1.5 mg/dl
8) Patients must be negative for Hepatitis virus B/C.
9) Patients must be more 20 year-old and less 80 year-old.
10) Written informed consent must be obtained from patients.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with multiple cancers
3) Patients with the past history of severe allergic reactions.
Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Noguchi |
Organization
Kurume University School of Medicine
Division name
Department of Urology
Zip code
Address
Asahi-machi 67, Kurume,
TEL
0942-31-7572
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University School of Medicine
Division name
Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code
Address
Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
TEL
0942-31-7744
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of medicine, Department of Immunology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2006 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 25 | Day |
Last modified on
| 2010 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001326
