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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

Closed to enrollment

More information

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

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DiagnosisAdvanced Non-CNS Tumors, Other solid tumours Study StatusClosed to enrollment
PhaseI
AgeChild, Adult - (2 Years to 21 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationIntralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance
Last Posted Update2022-10-04
ClinicalTrials.gov #NCT02756845
International Sponsor
Amgen
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

Our immune system has the ability to recognize and destroy cancer cells. Under certain circumstances (eg. mutation) these cancer cells are no longer destroyed. Immunotherapy is a treatment which aims to "mobilize" the patient's immune defenses against his disease, by restoring the ability of the immune system to act against cancer cells.Talimogen laherparepvec is a product that stimulates the production of cells specialized in destroying cancer cells after being injected directly into the tumor.

The objective of this study is to evaluate the positive and negative effects induced by the injection of this new treatment. To do this, initially, children with any type of solid tumors will receive injections of dose recalculated from the dose already known for treatment of adults.Then depending on the results, the doses are gradually reduced. The effectiveness of this treatment and the analysis of its side effects will be evaluated by observing the disease's evolution, the side effects and the duration of its effects.

Inclusion Criteria
  • Children 2 to 20 years old with a recurrent solid tumor
  • Subject must be a candidate for intralesional injection, defined as one or more of the following:
    • at least 1 injectable lesion ≥ 10 mm in longest diameter
    • multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.