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Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1

Phase 1
Conditions
on-CNS malignant solid tumor
Registration Number
JPRN-UMIN000007263
Lead Sponsor
Mie University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
9
Inclusion Criteria

Not provided

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) With lesions, such as visceral metastases or bone metastases, which need emergent therapies. 6) Use of anti-HSV drugs. 7) Use of steroids or immune-suppressive drugs. 8) Patients with severe complications. 9) Presence of central nervous system metastasis. 10) Lesion to be treated: high risk of bleeding. 11) Lesion to be treated: high risk of penetration or perforation. 12) Use of anti-platelet drugs or difficult to cessation of them. 13) Use of anticoagulant which is unsafe for intratumoral injection. 14) Pregnant or breastfeeding. 15) Patients who deny contraception during this study. 16) Any other cases that the attending doctor judges not appropriate to enroll to this study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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