Prevention of Thrombocytopenia in Glioblastoma Patients
Status:
Terminated
Trial end date:
2017-12-14
Target enrollment:
Participant gender:
Summary
Chemotherapy used in the treatment of primitive tumors of the central nervous system has a
particularly important platelet toxicity compared to chemotherapy used for treatment of other
tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The TP
and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or induced
(Gerber, 2006) can have dramatic consequences:
- specifically neurological (intratumoral bleeding with particularly important
neovascularization) with a functional aggravation and sometimes involvement of vital
prognosis,
- digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with
corticoids (potential gastric toxicity).
The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients
with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9, 8%),
has changed the standard of care of these patients (Stupp et al., 2009). Patients with newly
diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5 days per
week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg per square
meter of body-surface area per day, 7 days per week from the first to the last day of
radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg per
square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the
treatment of reference for glioblastoma and is used as a basis in various clinical studies
with new agents.
This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ
chemotherapy of glioblastomas.