Recruiting

Personalized Therapy

Sponsor:

St. Justine's Hospital

Code:

NCT02242552

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Pediatric Cancer

Study ID

NCT02242552

Start date

Jun, 2014

Status verified date

Aug, 2014

Completion date

Jun, 2017

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Feasibility of performing genomic data-based targeted therapy clinical trials in childhood cancers with poor prognosis, including relapsed or refractory cancers. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Monia Marzouki, MD

514-345-4931monia.marzouki@umontreal.ca

Hemrique Bittencourt, MD

514-345-4931henrique.bittencourt@umontreal.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T1C5

Contacts

Dominique Lafrenière, BScN, DESS

514-345-4969dominique.lafreniere@recherche-ste-justine.qc.ca

Mary-Ellen French, RN

514-345-4969mary-ellen.french@recherche-ste-justine.qc.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Sep 17, 2014

Last verified

Aug, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2014-09-17.