UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.
Title of the study (Brief title)	Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.
Region	Japan

Condition
Condition	Malignant solid tumor
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety, tolerability, and immune response in patients with NY-ESO-1-expressing malignant solid tumor treated with the IMF-001 and the immunological adjuvant MIS416.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	MTD, DLT and adverse effects.
Key secondary outcomes	Immune response

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	Vaccine
Interventions/Control_1	IMF-001, MIS416
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically confirmed malignant solid tumor. 2) Refractory to standard therapies. 3) NY-ESO-1 expression in tumor confirmed by immunohistochemistry or RT-PCR. 4) Life expectancy: >= 3 months from the date of consent. 5) Age: >= 20 years old. 6) Performance status (PS, ECOG scale): 0-2. 7) Adequate organ functions, measured as follows: White blood cells: >= 2,000/mm3 Hemoglobin: >= 8.0g/dl Platelet: >= 75,000/mm3 Total birilbin: <= 1.5 x ULN AST (GOT): <= 3.0 x ULN ALT (GPT): <= 3.0 x ULN Serum creatinine: <= 1.5 x ULN 8) >= 4 weeks from prior therapy at start of this treatment. 9) Written informed consent.
Key exclusion criteria	1) Past history of severe hypersensitivity. 2) Positive for HBs antigen, HCV antibody or HIV antibody. 3) Experience of autoimmune disease requiring treatment during 6 months prior to consent. 4) Active multiple primary malignancy. 5) Patient with disease requiring emergent radiotherapy. 6) Use of steroids (PSL >= 20mg / day) or immune-suppressive drugs. 7) Patients with severe complications. 8) History of other NY-ESO-1 related immunotherapy. 9) Pregnant or breastfeeding. 10) Patients who deny contraception during this study. 11) Any other cases that the attending doctor judges not appropriate to enroll to this study.
Target sample size	12

Research contact person
Name of lead principal investigator	Hiroshi Shiku
Organization	Mie University Graduate School of Medicine
Division name	Dep. of Cancer Vaccine / Immuno-Gene Therapy
Address	2-174 Edobashi, Tsu, Mie, Japan
TEL	059-231-5187
Email

Public contact
Name of contact person
Organization	Mie University Graduate School of Medicine
Division name	Dep. of Cancer Vaccine / Immuno-Gene Therapy Study Secretariat
Address	2-174 Edobashi, Tsu, Mie, Japan
TEL	059-231-5684
Homepage URL	http://www.shikuken.jp/
Email	cv-adm@doc.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Foundation
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

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

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	三重大学医学部附属病院（三重県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 21 Day
Last modified on	2017 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009417