Advanced primary malignant bone tumor Bone tumor
Conditions
Interventions
Repeated intratumoral local administration of survivin-responsive conditionally replicating adenovirus that targets and/or treats tumor cells with multiple factors-1 (Surv.m-CRA-1)
Sponsors
Nagano Satoshi
Surv BioPharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically diagnosed as primary malignant bone tumor 2)If standard treatment is preceded, More than 4 weeks has passed since prior standard treatment. 3)Not eligible for generally-accepted standard treatment that may achieve life-lengthening or palliative effect. 4)With a lesion measurable disease of short, long diameters and height and the lesion can be intratumorally injected with Surv.m-CRA-1. 5)Aged 10 years or older and younger than 85 years at the time of the consent. 6)ECOG performance status of 0-2. 7)Life expectancy for longer than 3 months. 8)Adequate organ function as defined below (Most recent test result in two weeks from registration) Hb >= 7 g/dL WBC >= 2,000 /microL Plt >= 50,000 /microL AST (GOT) =< 100 U/L ALT (GPT) =< 100U/L Total BIl. =< 2.0 mg/dL Serum Cr. =< 2.0 mg/dL 9) Use of effective contraception, if procreative potential exists. 10) Provide written informed consent Written consent for participation for the trial is obtained from the patient or proxy.
Exclusion criteria
Exclusion criteria: 1) Patients with the following illness with any comorbidity Severe heart disease, respiratory disease, digestive disease or liver disease. Uncontrolled diabetes Infectious disease that needs continuous treatment 2) A history of allergic reactions History of allergy to penicillin, pork or beef (including milk) 3) Ongoing illness that needs requires immunosuppressant or corticosteroid administration 4) Active double cancer (Excluding resected basal cell carcinoma, intraepithelial carcinoma, superficial bladder carcinoma, or malignant tumor relapse-free for more than 5 years) 5) Uncontrollable fever or pain from the tumor 6) Pregnant, breast-feeding or woman with positive for pregnancy test woman before or less than within 1 year from after menopause. 7) Treated with non-approved drug in less than within 4 weeks before consent of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall effect of local response based on the Choi criteria (central data review committee) | — |
Secondary
| Measure | Time frame |
|---|---|
| Local esponse based on the Choi criteria and RECIST (central data review committee, principal investigator or subinvestigator), Systemic response based on RECIST (central data review committee), Local esponse based on the iRECIST (principal investigator or subinvestigator), Tumor diameter reduction rate, Changes in ADC Values by Diffusion-Weighted MRI, Progression free survival rate (PFS), Overall survival rate (OS), Performance status and Pain (Visual analogue scale), Evaluation of affected limb function, Analysis of Survivin expression, Adverse event | — |
Contacts
Public ContactToshitaka Futagatwa
Kagoshima University Hospital
Outcome results
None listed