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| Diagnosis | Low grade glioma, high grade glioma, plexiform neurofibroma | Study Status | Closed to enrollment |
| Phase | I/II |
| Age | Child, Adult - (1 Month to 25 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Trametinib (oral) |
| Last Posted Update | 2022-09-30 |
| ClinicalTrials.gov # | NCT03363217 |
International Sponsor
St. Justine's HospitalPrincipal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Genevieve Legault
CHU Ste-Justine – Dr. Sébastien Perreault
CHU de Quebec – Dr. Valerie Larouche
Alberta Children’s Hospital – Dr. Lucie Lafay-Cousin
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
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
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens
Study Description
This is a study of trametinib (an oral drug called a MEK inhibitor) in children and adolescents who have any of the following types of cancer or tumours:
- patients with neurofibromatosis type 1 (NF1) that have low grade glioma, or
- patients with neurofibromatosis type 1 (NF1) that have plexiform neurofibroma,
- patients with low grade glioma that has a gene change called a BRAF fusion (in the tumour)
- patients with glioma of any grade (low or high) with activation of proteins called the MAPK/ERK pathway.
For all patients (except for those with plexiform neurofibroma), the disease must have recurred or grown in size after a first treatment.
Inclusion Criteria
- Patient must be aged ≥ 1 month (corrected age) to ≤ 25 years at the time of study enrollment
- Participants must belong to one of the groups described in the study description section
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications
Perreault S, Larouche V, Tabori U, Hawkin C, Lippé S, Ellezam B, Décarie JC, Théoret Y, Métras MÉ, Sultan S, Cantin É, Routhier MÈ, Caru M, Legault G, Bouffet É, Lafay-Cousin L, Hukin J, Erker C, Jabado N. A phase 2 study of trametinib for patients with pediatric glioma or plexiform neurofibroma with refractory tumor and activation of the MAPK/ERK pathway: TRAM-01. BMC Cancer. 2019 Dec 27;19(1):1250. doi: 10.1186/s12885-019-6442-2.
