Glioblastoma Clinical Trial
Official title:
Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients
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.
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