This trial was co-financed with the Children without Cancer race of 2012
VINILO – Phase I-II Study of Vinblastine in combination with Nilotinib in Children and Adolescents with Refractory or Recurrent Low-Grade Glioma (a SIOPE-Brain Tumor and ITCC protocol) – focuses on low grade gliomas, most frequent brain tumors of children.
Project Summary
Low-grade gliomas are the most common brain tumors in children. These tumors are usually treated with chemotherapy (Vinblastine), which typically causes them to regress or stabilize. However, after stopping chemotherapy, the tumor reappears in more than 2 out of 3 cases.
The European ITCC network selected this phase I and II project in 2012 for its potential to test the effectiveness of combining vinblastine with a new treatment for these pediatric tumors.
The goal of this trial is to achieve a therapy that allows the tumor to regress or at least stabilize in a durable manner, even after chemotherapy is stopped. The trial will test a combination of two drugs that will prevent the establishment and maintenance of the blood vessel network that tumors build and need to continue growing. One of these chemotherapy drugs is vinblastine, well known to pediatric oncologists. The other is a new drug, never before used in children, nilotinib, which inhibits the PDGF receptor, essential for blood vessel growth.
Initially, this trial aimed to include 150 children in 40 centers across Europe in France, the United Kingdom, Italy, Germany, Austria, Spain, Switzerland, Denmark, and the Netherlands.
The principal investigator is Dr. Jacques Grill from the Gustave Roussy Institute in Villejuif. The co-investigators are Dr. Sue Picton (Leeds, United Kingdom), Giorgio Perilongo (Padua, Italy), Pablo Hernaiz-Driever (Berlin, Germany), and Amadeo Azizi (Vienna, Austria).
Follow-up of the VINILO Trial:
- Phase I Results (Completed): 75% of patients treated after failing a first treatment had tumor regression or stabilization.
- Phase II Results (Completed): Currently under analysis.
- Scientific Presentations of VINILO:
- Phase I results were presented at the annual ASCO conference in Chicago, United States, in 2016.
- Publication of phase I in the journal “Neuro-Oncology Advances” on June 9, 2020: Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma
- A publication corresponding to phase II is being prepared.
Project Summary:
- Sponsor: Gustave Roussy Institute
- Principal Investigator: Dr. Jacques Grill
- Program Duration: July 2013 – January 2020 (2 years Phase I, 3 years Phase II, 2 years follow-up)
- Phase I Recruitment (Completed): 35 patients included
- Phase II Recruitment (Completed): 109 patients included
- Total Recruitment: 144 patients
- Countries Involved: France, United Kingdom, Italy, Germany, Austria, Spain, Switzerland, Denmark, and the Netherlands
- Funding from Imagine for Margo (Phase I): €180,000
- Other Co-Funder: National Cancer Institute (INCa)
Doctor Jacques Grill speaks about the program :
The first results of phase I of the VINILO therapeutic trial were presented to the ASCO (American Society of Clinical Oncology) in 2016 and show that 75% of patients have had a total or partial response to the treatment. 7 children have ended their year of treatment without the illness growing.
Phase 2 has received authorizations to start on June 15th, 2016.
PR Gilles Vassal, Chairman of ITCC and Head of Clinical Research of Gustave Roussy, presents during the great congress of the ASCO in Chicago the kick-off of target therapies for children and the need to change European pediatric regulations to incent industrial investment in children’s cancers.
