UMIN-CTR Clinical Trial

Basic information
Public title	Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy
Acronym	Peptide vaccination for patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy
Scientific Title	Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy
Scientific Title:Acronym	Peptide vaccination for patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy
Region	Japan

Condition
Condition	Urotherial cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Peptides (maximum 4) among 34 (12 for HLA-A2, 14 for HLA-A24 and 8 for HLA-A3 super type) peptides, which were identified as vaccine candidates for HLA-A2, HLA-A24 or HLA-A3 super type positive advanced/metastatic urotherial cancer patients, are administered into urotherial cancer patients after confirmation of peptide-specific IgG in patients. The aim of the study is to investigate adverse effects (evaluation of safety), anti-tumor effect (clinical responses), total survival of vaccinated patients, and immunological responses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation (clinical responses) of anti-tumor effects of peptide vaccination.
Key secondary outcomes	1.Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination. 2.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. Evaluation of long-term prognosis (progression free survival and total survival). 3.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	(1st treatment:total 12 times, every week) Day 1: Select peptide candidates (up to 4), to which 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). Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 85: Final evaluation. The 1st treatment (total 12 times, every week) is finished, but the 2nd treatment would be continued according to the patient's request. The schedule will be determined based on the reactivity to peptides. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be changed.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects must satisfy the following conditions. 1)Patients must be diagnosed as urotherial cancer pthologically at the inithial treatment. The patients must be suffering from advanced/metastatic urotherial cancer after M-VAC (methotrexate, vinblastine, doxorubicine and cisplatin) chemotherapy. 2)Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 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 Hb >= 8.0g/dl Platelet >= 100,000/mm3 Lymphocyte >= 10,000/mm3 Serum Creatinine <= 1.5 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 85 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	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nasanori Noguchi
Organization	Kurume University School of Medicine
Division name	Department of Urology
Zip code
Address	asahi-machi 67, Kurume,
TEL	0942-31-7572
Email

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	Asahi-machi 67, Kurume,
TEL	0942-31-7572
Homepage URL
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of medicine, Department of Immunology
Institute
Department

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	The Ministry of Health, Labor and Welfare, Japan
Name of secondary funder(s)

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

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 03 Month 10 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	2007 Year 12 Month 27 Day
Date of IRB	2007 Year 12 Month 27 Day
Anticipated trial start date	2008 Year 03 Month 01 Day
Last follow-up date	2012 Year 02 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 02 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001288