Patients with multiple brain metastases from solid tumors. MedDRA version: 12.0 Level: HLGT Classification code 10027476 Term: Metastases
Conditions
Interventions
Product Name: L19 antibody in SIP format
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: L19SIP
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
PHILOGEN S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Unresectable multiple brain metastasis from histologically or cytologically confirmed solid tumors Males or females, age > 18 years Measurable disease defined as at least one metastatic brain lesion that can be accurately and serially measured by the modified RECIST criteria (version 1.1) Prior therapy for metastatic disease allowed ECOG performance status 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L Total bilirubin ≤ 30 ?mol/L (or ≤ 2.0 mg/Dl) ALT and AST ≤ 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary ocular melanoma Patients with brain metastasis amenable for surgical excision or stereotactic irradiation (radiosurgery) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated Grade II, New York Heart Association (NYHA) criteria) Uncontrolled hypertension Ischemic peripheral vascular disease (Grade IIb-IV) Severe diabetic retinopathy Active autoimmune disease History of organ allograft or stem cell transplantation Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment Breast feeding female Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment Growth factors or immunomodulatory agents within 7 days of the administration of study treatment Patients in need of systemic treatment for rapidly progressive systemic disease during study treatment and up to 6 weeks after injection of therapeutic 131I-L19SIP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Selective uptake of 131I-L19SIP or 124I-L19SIP in brain lesions. - Safety of combined administration of 131I-L19SIP and WBRT.;Secondary Objective: - Intracranial, extra cranial and overall response - Overall survival - Clinical performance index;Primary end point(s): | — |
Countries
Italy, United Kingdom
Outcome results
None listed