Phase II trial of Survivin-responsive oncolytic adenovirus (Surv.m-CRA-1) by repeated intratumoral injection in advanced bone tumor patients.

JRCT ID: jRCT2073210118

Registered date:22/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced primary malignant bone tumor
• Date of first enrollment: 22/01/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Repeated local administration Survivin-responsive conditionally replicating adenovirus (Surv.m-CRA-1)

Outcome(s)

• Primary Outcome: Overall response rate by the central data review committee (RECIST)
• Secondary Outcome: Response rate by the central data review committee (Choi criteria), Response rate by the principal investigator or subinvestigator (RECIST, Choi criteria), Tumor diameter reduction rate, Progression free survival rate, Overall survival rate, Performance status and Pain (Visual analogue scale), Evaluation of affected limb function, Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 10age old
• Age maximum: < 85age old
• Gender: Both

Include 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 to 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.

Exclude 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.

Related Information

• Primary Sponsor: Nagano Satoshi
• Secondary Sponsor: Japan Agency for Medical Research and Development