UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005246
Receipt number R000006208
Scientific Title Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer
Date of disclosure of the study information 2011/03/14
Last modified on 2016/03/14 12:51:27

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Basic information

Public title

Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer

Acronym

Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer

Scientific Title

Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer

Scientific Title:Acronym

Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer

Region

Japan


Condition

Condition

Refractory Urothelial or Prostate Cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety, tolerability and immune response in NY-ESO-1-expressing refractory urothelial or prostate cancer patients treated with the CHP-NY-ESO-1 cancer vaccine and the immunological adjuvant MIS416.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Maximum tolerated dose (MTD), dose limiting toxicity (DLT) and adverse effects.

Key secondary outcomes

Immune response, quality of life (EORTC QLQ-C30), and the change in serum PSA level (prostate cancer only)


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

CHP-NY-ESO-1, 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)Histologically documented i) urothelial or ii) prostate cancer.
2)Refractory to standard therapy.
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.
6)Performance status (ECOG scale): 0-2.
7)Adequate organ functions, measured as follows:
White blood cells: >= 2,000/mm3
Hemoglobin: >= 8.0 g/dl
Thrombocytes: >= 7.5 x 10000/mm3
Total birilbin: <= 1.5 x ULN
Aspartate aminotransferase (AST, GOT): <= 3 x ULN
Alanine aminotransferase (ALT, GPT): <= 3 x ULN
Serum creatinine: <= 1.5 x ULN
8)Time from prior therapy:
>= 2 weeks after the last administration date of prior chemotherapy.
>= 2 weeks after the last radiation date of prior radiotherapy.
>= 4 weeks after the date of last surgery.
>= 4 weeks after the last treatment date of prior immunotherapy.
9)Cooperativeness to written informed consent must be obtained and documented.

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 preceding the day of consent.
4)Active multiple primaries. Simultaneous or metachronous with disease-free interval of 5 years or more.
5)Patient with disease requiring emergent radiotherapy.
6)Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosup-pressive drugs.
7)Patients with severe complication(s).
8)History of other NY-ESO-1-related immunotherapy.
9)Pregnant, lactating, or unprotected female.
10)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

1st name
Middle name
Last name Yoshiki Sugimura

Organization

Mie University Graduate School of Medicine

Division name

Department of Nephro-Urologic Surgery and Andrology

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Mie University Hospital

Division name

Department of Nephro-Urologic Surgery and Andrology

Zip code


Address


TEL


Homepage URL


Email

uroclin5@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name



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)



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

2011 Year 03 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially 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

2010 Year 12 Month 18 Day

Date of IRB


Anticipated trial start date

2011 Year 03 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

2011 Year 03 Month 14 Day

Last modified on

2016 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006208


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name