CompletedNot Applicable

Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

Spain13 participantsStarted 2017-09-06

Plain-language summary

Phase I study, single site, open label with dose escalation, for evaluate safety and the oncolitic Adenovirus VCN-01 activity in patients with refractory retinoblastoma.

Who can participate

Age range1 Year – 12 Years

SexALL

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Inclusion criteria

✓. Patients with retinoblastoma with a somatic mutation of the geneRB1 and active tumor in a single eye, or germinal mutation of RB1 with active tumor/s in an eye and the contralateral eye unaffected, enucleated or without tumor activity. In both cases, relapsed or refractory with the use of systemic, intraarterial or intravitreal chemotherapy or radiotherapy, in accordance with the availability at his/her referral site, in whom enucleation is the only recommended treatment under opinion of the medical team treating the case at the originating referral site.
✓. 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).
✓. Normal Hepatic function: serum ALT: \<0,52μkat/L (de 9 months -12 years); serum AST: 61-80 g/L (8 months - 5 years); 63-83 g/L (5-9 years); 63-82 g/L (9-12 years).
✓. Adequate marrow reserve manifested in an absolute neutrophil count\> 1000 / mm3, platelets\> 100,000 / mm3 and hemoglobin\> 8 g / dl, without transfusional or cytokine support at least one month prior to study entry.
✓. Age greater than one year and less than 12 years at the time of inclusion in the study.
✓. Informed consent form signed.

Exclusion criteria

✕. Presence of factors that require immediate enucleation of the affected eye such as glaucoma, rubeosis iridis, anterior chamber involvement.
✕. Comorbidities: Uncontrolled epilepsy with anticonvulsant treatment, cardiac disease not compensated by treatment.
✕. Active Infections.
✕. Other chronic or active acute diseases that under the criterion of the researcher were an exclusion criterion.
✕. History of having received attenuated or live vaccines in the 30 days prior to inclusion in the study.
✕. Any cause of Immunosuppression.
✕. Trilateral Retinoblastoma.
✕. Extraocular spread.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: 180 days

Trial details

NCT IDNCT03284268

SponsorFundació Sant Joan de Déu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More Retinoblastoma, Recurrent trials