Personalized Targeted Therapy in Refractory or Relapsed Cancer in Childhood

Pediatric Cancer Clinical Trial

Official title:

Personalized Targeted Therapy in Refractory or Relapsed Cancer in Childhood(TRICEPS Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242552
• Other study ID #: Triceps
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: September 15, 2014
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2014
• Source: St. Justine's Hospital
• Contact: Monia Marzouki, MD
• Phone: 514-345-4931
• Email: monia.marzouki[@]umontreal.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A new research paradigm that involves sequencing tumor DNA/RNA to identify driver mutations, select among the Health Canada approved drugs (for adult cancers) known to block certain oncogenic pathways, and recommend these drugs to the treating physician, without taking into account the tumor histology.

In this paradigm, the treatment is targeted to the actionable mutation(s) i.e. those driving oncogenesis. It is also personalized to the molecular signature of the patient's tumor, irrespective of its histopathological subtype. The experience of the investigators team in genomics, including next generation sequencing and bioinformatic analysis combined with the clinical expertise, bring at last this approach within our technical capacities. In parallel, the number of Health Canada-approved drugs (which have been tested in a pediatric setting) designed to interfere with oncogenesis pathways is increasing exponentially.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 21 Years

Eligibility

Inclusion Criteria:

At the time of enrollment:

• 21 year-old or less

• Poor prognosis biopsy-proven cancer of any type :

• Cancer (at initial diagnosis) known to be refractory to treatment

• Or cancer refractory to treatment

• Or relapsed cancer

• Written informed consent by patient, parents, or the legal guardians

Exclusion Criteria:

• Estimated life expectancy of less than 3 months.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric Cancer

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of performing genomic data-based targeted therapy clinical trials in childhood cancers with poor prognosis, including relapsed or refractory cancers.	The study team will evaluate the timeline between decision of biopsy, the actual biopsy, availability of results of the whole-genome analysis, interpretation of results and divulgation of results to patient and family.	24 months	No
Secondary	Number of children with cancer who are suitable candidates for targeted therapy at our institution each year.		24 months	No
Secondary	Number and type of driver mutation(s) found in our population of recurrent or refractory cancers.		24 months	No
Secondary	Number of cancer patients who harbour actionable driver mutation(s) that can be targeted with a Health Canada approved targeted drug.		24 months	No
Secondary	Feasibility of performing whole genome sequencing and data analysis, identifying a drug based on the genomic data and offering this information to the medical team, the patient and the family within 10-week time frame from diagnosis		24 months	No