Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma (RTB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03284268|
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma, Recurrent||Genetic: VCN-01||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||September 25, 2019|
|Estimated Study Completion Date :||November 25, 2019|
Experimental: Dose escalation of VCN-01
Dose lower : 2E+9 viral particules/eye Dose medium: 2E+10 viral particules/eye Dose high: 2E+11 viral particules/eye
VCN-01 intravitreal injection
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 180 days ]The safety and tolerability of two intravitreal injections of VCN-01 will be determined with dose escalation until the maximum tolerated dose (MTD) is established based on the evaluation of adverse events and the observation of any dose-limiting toxicity (TLD).
- Tumor response [ Time Frame: 28 days ]Tumor response rate (ORR) to VCN-01 at 28 days post-administration.
- VCN-01 [ Time Frame: 180 days ]Virus presence in blood samples, aqueous humor, ocular surface and nasal swabs, and its difference between the viral particles before and after the treatment to evaluate the excretion profile of the CNV-01.
- Immune response [ Time Frame: 180 days ]The presence of neutralizing antibodies in blood samples in study patients to assess the immune response.
- Histopathology of enucleated eyes after treatment with VCN-01 [ Time Frame: 180 days ]Presence of VCN-01 in vitreous humor samples of enucleated eyes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284268
|Contact: Jaume Catalá Mora, Dr.||932 53 21 00||Jmora@sjdhospitalbarcelona.org|
|Contact: Guillermo Chantada, Dr||932 53 21 firstname.lastname@example.org|
|Hospital Sant Joan de Déu||Recruiting|
|Barcelona, Spain, 08950|
|Contact: Jaume Catalá Mora, Dr 932 53 21 00|
|Principal Investigator:||Jaume Catalá Mora, DR||Hospital Sant Joan de Deu|