Clinical protocol for newly diagnosed patients
In March 2011, the treatment protocol ‘DIPG study VUmc 01’ was opened for participation in VUmc.
Children with a pontine glioma have a very poor prognosis as the current standard treatment only involves radiation which allows children to recover for a short period but then the tumor usually continues to grow.
The DIPG Vumc 01 treatment protocol is a study, which means that it is not yet known if the treatment improves the prognosis for children with a pontine glioma. The protocol was modified early 2011, after national and international consultations, and the high dosis of chemotherapy, which was originally part of the protocol, was removed. Furthermore, patients with progression can now also apply for the study, they will then enter the research in phase b.
The research consists of three phases: a, b and c.
At the diagnosis, parents and child will be asked if a biopt (a small part of the tumor) may be taken. The research team will use it to examine that type of tumor, but also to discover if the tumor contains specific proteins that can be addressed by medicines from phase b. The biopt is not mandatory; participation in the study is also possible without a biopt.
Phase a: The standard radiation is combined with the medicine Gemcitabine. This medicine penetrates well into the brain and reinforces the effect of the radiotherapy.
Phase b: If the tumor continues to grow, the child can be treated with a combination of protein-targeted medicines and chemotherapy. This involves the medicines Erlotinib, Everolimus, Bevacizumab and Irinotecan. Research is done to see if this combination is well tolerated and if it inhibits tumor growth. Children from phase a as well as those children who only got irradiated, can participate in phase b.
Phase c: This phase starts when the studies from phase a and b have been completed and have been proven safe. The phase c study combines phase a and b. The combination of Gemcitabine and radiotherapy (phase a) will directly be followed by the combination of Erlotinib, Everolimus, Bevacizumab and Irinotecan (phase b), without any delay when the tumor could grow further. Currently, this research is only carried out in VUmc but the objective is to make this research also available in other academic hospitals in the future.