UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Acronym	Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Scientific Title	Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Scientific Title:Acronym	Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Region	Japan

Condition
Condition	Malignant solid tumors, Malignant lymphoma, Multiple Myeloma, Acute leukemia
Classification by specialty	Medicine in general Hematology and clinical oncology Surgery in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	1. Safety Evaluation by NCI-CTCAE ver 3.0 2. Efficacy Clinical response rate Disease control rate
Key secondary outcomes	1. QOL outcomes 2. Immune responses to WT1

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 Vaccine
Interventions/Control_1	The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed 12 times at weekly intervals. The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria from 1 to 3 weeks after 12th WT1 vaccination .
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	16 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Diagnosed as malignant solid tumors, malignant lymphoma, mutiple myeloma or acute leukemia. 2. Informed about his diagnosis 3. Not expected to make any further efficacy by standard treatment 4. WT1 expression in malignant cells 5. HLA-A*2402 positive 6. Having evaluable diaseas 7. No chemotherapy/radiation has been performed within 4 weeks and no hormone/BRM therapy has been performed within 3 weeks before the start of vaccination. 8. There is not uncontrolable brain metastasis. 9. Performance status (ECOG) 0-1 10. Meet the following criteria for organ functions 1)Neutrophil more than 1,000/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl 2) Serum creatinine less than 2.0 mg/dL 3) Serum bilirubin less than 1.5 folds of the upper normal limit 4) Serum AST/GOT less than 3 folds of the upper normal limit 5) Serum Albumin more than 2.5g/dl 6) Arterial oxygen saturation more than 94% in room air 11. Pleural effusion, ascites and pericardial effusion are not detected or controlled. 12 Survival period is expected more than 3 months 13. Informed consent has been obtained
Key exclusion criteria	1. There is deep-seated active infection. 2,3 There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition(TPN) 5. There is expanded liver metastasis. 6. There are other malignancies. 7. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 8. Post allogeneic hematopoietic stem cell transplantation 9. Pregnant or lactating woman 10. There is severe psychiatric disorder. 11. Responsible doctors judged the patient inappropriate for the trial
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Haruo Middle name Last name Sugiyama
Organization	Osaka University Graduate School of Medicine
Division name	Department of Clinical Laboratory Science
Zip code	565-0871
Address	1-7, Yamada-oka, Suita City, Osaka , Japan
TEL	06-6879-2593
Email	sugiyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Oka Middle name Last name Yoshihiro
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cancer Immunotherapy
Zip code	565-9871
Address	2-2, Yamada-oka, Suita City, Osaka, Japan
TEL	06-6879-3676
Homepage URL	http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/index.htm
Email	yoshi@cit.med.osaka-u.ac.jp

Sponsor
Institute	Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Academic Clinical Research Center of Osaka University Hospital
Address	2-2 yamada-0ka, Suita Cit, Osaka
Tel	0662108290
Email	acr-jim@dmi.med.osaka-u.ac.jp

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	2009 Year 05 Month 24 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	No longer recruiting
Date of protocol fixation	2003 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2003 Year 11 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 05 Month 24 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002437