A Phase I, unicentric, open and dose escalation clinical trial to evaluate the safety and the activity of the oncolytic adenovirus VCN-01 in patients with refractory retinoblastoma

Fundació Sant Joan de Déu0 个研究点开始时间: 2017年5月23日最近更新: 2017年8月21日

试验速览

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•1. Patients with retinoblastoma both with somatic mutation of the RB1gen with active tumor in a single eye, as with germinal mutation of the RB1gen with active tumor in a single eye and the not affected fellow eye or with active tumor in a single eye and the fellow eye already enucleated relapsed or refractories with the use of systemic chemotherapy, intra-arterial or intravitreal or radiotherapy in whom enucleation is the only advisable treatment.
•2. Normal renal function: serum creatinine: <45µmol/L (0-2 years); <57µmol/L (3-6 years); <60µmol/L (7-10 years); <80µmol/L (11-13 years).
•3. Normal liver function: serum ALT: <0,52µkat/L (from 9 months to 12 years); serum AST: 61-80 g/L (from 8 months to 5 years); 63-83 g/L (5-9 years); 63-82 g/L (9-12 years).
•4. Adequate bone-marrow reserve expressed in an absolute neutrophil count > 1000/mm3, platelets >100.000/mm3 and hemoglobin >8 g/dl, without transfusional support.
•5. Older than one year and youger than 12 years at the time of inclusion in the study.
•6. Signed informed consent form.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 13
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of factors that require immediate enucleation of the affected eye as can be glaucoma, rubeosis iridis, commitment on the anterior chamber.
•2. Comorbidity situations: uncontrolled epilepsy with anticonvulsant treatment, no compensated cardiological disease with the treatment.
•3. Active infections.
•4. Other chronic or acute active diseases that would be an exclusion criteria under the criterion of the investigator.
•5. Having received attenuated or live vaccines background in the 30 days prior to the inclusion in the study.
•6. Immunosuppression of any cause.
•7. Trilateral retinoblastoma.
•8. Extraocular extension.
•9. Antecedent of having received treatment for retinoblastoma with chemotherapy or radiotherapy by any route in the 30 days before the inclusion in the study.
•10. Patients who cannot complete the study procedures for psychological or social reasons.
•11. Pregnancy. Female potential of childbearing patients should agree with doing a blood or urine pregnancy test and the result shall be negative to enter into the study.

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