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Personalized Targeted Therapy in Refractory or Relapsed Cancer in Childhood

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Dr Monia Marzouki, St. Justine's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02242552
First Posted: September 17, 2014
Last Update Posted: September 17, 2014
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Monia Marzouki, St. Justine's Hospital
  Purpose

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.


Condition
Pediatric Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Personalized Targeted Therapy in Refractory or Relapsed Cancer in Childhood(TRICEPS Study)

Further study details as provided by Dr Monia Marzouki, St. Justine's Hospital:

Primary Outcome Measures:
  • 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 ]
    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.


Secondary Outcome Measures:
  • Number of children with cancer who are suitable candidates for targeted therapy at our institution each year. [ Time Frame: 24 months ]
  • Number and type of driver mutation(s) found in our population of recurrent or refractory cancers. [ Time Frame: 24 months ]
  • Number of cancer patients who harbour actionable driver mutation(s) that can be targeted with a Health Canada approved targeted drug. [ Time Frame: 24 months ]
  • 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 [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Blood, saliva, tumor sample (bone marrow or solid tumors)

Estimated Enrollment: 30
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with Relapse or refractory leukemia and solid tumor
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02242552


Contacts
Contact: Monia Marzouki, MD 514-345-4931 ext 6316 monia.marzouki@umontreal.ca
Contact: Hemrique Bittencourt, MD 514-345-4931 ext 2724 henrique.bittencourt@umontreal.ca

Locations
Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T1C5
Contact: Dominique Lafrenière, BScN, DESS    514-345-4969    dominique.lafreniere@recherche-ste-justine.qc.ca   
Contact: Mary-Ellen French, RN    514-345-4969    mary-ellen.french@recherche-ste-justine.qc.ca   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Monia Marzouki, MD St. Justine's Hospital
  More Information

Responsible Party: Dr Monia Marzouki, Hematologist/Oncologist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02242552     History of Changes
Other Study ID Numbers: Triceps
First Submitted: August 15, 2014
First Posted: September 17, 2014
Last Update Posted: September 17, 2014
Last Verified: August 2014