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

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Brief Title

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

Official Title

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

Brief 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.
    



Study Type

Interventional


Primary Outcome

Incidence of Treatment-Emergent Adverse Events

Secondary Outcome

 Tumor response

Condition

Retinoblastoma, Recurrent

Intervention

VCN-01

Study Arms / Comparison Groups

 Dose escalation of VCN-01
Description:  Dose lower : 2E+9 viral particules/eye Dose medium: 2E+10 viral particules/eye Dose high: 2E+11 viral particules/eye

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

13

Start Date

September 6, 2017

Completion Date

April 30, 2021

Primary Completion Date

September 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          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 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).

          4. 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.

          5. Age greater than one year and less than 12 years at the time of inclusion in the
             study.

          6. Informed consent form signed.

        Exclusion Criteria:

          1. Presence of factors that require immediate enucleation of the affected eye such as
             glaucoma, rubeosis iridis, anterior chamber involvement.

          2. Comorbidities: Uncontrolled epilepsy with anticonvulsant treatment, cardiac disease
             not compensated by treatment.

          3. Active Infections.

          4. Other chronic or active acute diseases that under the criterion of the researcher were
             an exclusion criterion.

          5. History of having received attenuated or live vaccines in the 30 days prior to
             inclusion in the study.

          6. Any cause of Immunosuppression.

          7. Trilateral Retinoblastoma.

          8. Extraocular spread.

          9. History of having received treatment for retinoblastoma with chemotherapy or radiation
             therapy by any means within 30 days prior to inclusion in the study.

         10. Patients who can not complete the study procedures for reasons psychological or
             social.

         11. Pregnancy. Female patients with procreative potential should be agree to undergo a
             blood or urine pregnancy test and the result should be negative to enter the study.
      

Gender

All

Ages

1 Year - 12 Years

Accepts Healthy Volunteers

No

Contacts

Jaume Catalá Mora, Dr, 932 53 21 00, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT03284268

Organization ID

FSJD-RTB-2015


Responsible Party

Sponsor

Study Sponsor

Fundació Sant Joan de Déu


Study Sponsor

Jaume Catalá Mora, Dr, Principal Investigator, Hospital Sant Joan de Deu


Verification Date

February 2020