Advanced solid tumors for whom no standard therapy is available (primary malignant bone tumor, metastatic malignant bone tumor, primary malignant soft tissue tumor, metastatic malignant soft tissue tumor)
Conditions
Interventions
Single, intratumoral administration of Surv.m-CRA-1
Sponsors
Department of Gene Therapy and Regenerative Medicine, Graduate School of Medical and Dental Sciences, Kagoshima university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed as one of followings; primary malignant bone tumor metastatic malignant bone tumor primary malignant soft tissue tumor metastatic malignant soft tissue tumor 2) More than 4 weeks has passed since prior standard treatment 3) No standard therapy is available 4) With a measurable disease of short, long diameters and height and the lesion has enough volume to be injected with Surv.m-CRA-1. 5) Aged 10 years or older and younger than 85 years at the time of consent. 6) Performance status of 0~2. 7) Life expectancy of longer than 3 months 8) Adequate organ function as defined below: Hb => 8 g/dL WBC => 2,000 /microL Plt => 70,000 /microL AST(GOT) <= 100 U/L ALT(GPT) <= 100 U/L Total bil <= 1.5 mg/dL Serum Cr <= 2.0 mg/dL 9) Use of effective contraception, if procreative potential exists. 10) Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with the following illness: Severe heart disease, respiratory disease, digestive disease or liver disease. Uncontrolled diabetes Infectious disease that needs continuous treatment 2) A history of allergic reactions to penicillin, pork or beef (including milk) 3) Ongoing illness that requires immunosuppressant or corticosteroid administration 4) Currently active or past malignancies within the past five years 5) Uncontrollable fever or pain from the tumor 6) Pregnant, breast-feeding or woman with positive pregnancy test within 1 year after menopause. 7) Treated with non-approved drug within 4 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Detection of adenovirus in peripheral blood 2) Urinary excretion of Adenovirus 3) Adenoviral titer 4) Cytokines 5) Local response rate 6) Reduction rate in long diameter of the tumor 7) Pathological evaluation for tumor necrosis 8) Adenovirus infection in tumor 9) Performance status and visual analogue scale 10) Function of affected limb | — |
Countries
Japan
Contacts
Public ContactToshitaka Futagawa
Kagoshima University Hospital Division of Clinical Trial, Clinical Research Management Center
Outcome results
None listed