臨床研究等提出・公開システム

Oncolytic herpes simplex virus type I (HSV-1) virus therapy using G47delta for patients with prostate cancer

Oncolytic virus therapy using G47delta for patients with prostate cancer

Hiroshi Fukuahra

Kyorin University School of Medicine

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

hifukuha@gmail.com

Hiroshi Fukuhara

Kyorin University School of Medicine

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

+81-422-47-5511

hifukuha@gmail.com

Recruiting

Feb. 14, 2022

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

Patients who meet all of the following conditions are targeted.
1) Patients who had prostate cancer that was newly diagnosed
2) Patients willing to undergo long-term androgen depletion therapy
3) WHO Performance Status: 0-1 patients
4) Patients with metastases confirmed by imaging before 12 weeks of enrollment
5) Patients who have not started androgen depletion therapy before 12 weeks of enrollment
6) Age: Men over 20 years old
7) Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's voluntary written consent after sufficient understanding
8) Patients with the following data within 14 days before registration
Number of neutrophils 1,500 / mm3 or more
Platelet count 10x104 / mm3 or higher
AST (GOT) 75 U / L or less (2.5 times the standard value)
ALT (GPT) 105 U / L or less (2.5 times the standard value)
Total bilirubin value 2.25 mg / dL or less (1.5 times the standard value)
Serum potassium level 3.5 mmol / L or higher
eGFR 30 ml / min / 1.73 mm2 or more

Those who meet any of the following conditions are not eligible.
1) Patients who have undergone radical treatment for prostate cancer
2) Patients with metastases to the brain or pia mater
3) Patients receiving chemotherapy for prostate cancer
4) Patients who have received androgen depletion therapy before 12 weeks of enrollment
5) Patients with concurrent active double cancer at enrollment
6) Patients who have undergone surgery for benign prostatic hyperplasia such as TURP within the past 4 weeks
7) Patients participating in clinical trials / clinical studies of unapproved drugs within 30 days prior to participation in this study
8) Patients with a history of virus therapy
9) HIV positive or pre-existing patients
10) Patients with active herpesvirus infection
11) Patients with alcohol or other drug addiction
12) Patients with active and uncontrolled infections
13) Patients with uncontrolled or severe heart failure / diabetes / hypertension / interstitial pneumonia / renal failure / autoimmune disease
14) Patients with allergies to anti-HSV drug (acyclovir)
15) In addition, patients who are judged by the investigator or the investigator to be inappropriate for conducting this study safely

Male

prostae cancer

Intratumoral inoculation of G47delta (1 x 10<9> pfu) given on day 1, day 8 and every 4 weeks thereafter, up to 6 times.

prostate cancer, oncolytic, genetically engineered virus, virus therapy, gene therapy, cancer treatment, herpes simplex virus type1

C12

1-year failure-free survival rate

Statistical analysis of 1-year failure-free survival rate, overall survival, failure-free survival, adverse event rate,
severe adverse event rate

+81-3-5841-0818

Dec. 28, 2020

No

none