UMIN-CTR Clinical Trial

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

Refractory Urothelial or Prostate Cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name

Organization

Foundation

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

03

Month

14

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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