Prevention of Thrombocytopenia in Glioblastoma Patients (PLATUM)
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|ClinicalTrials.gov Identifier: NCT02227576|
Recruitment Status : Terminated (Study halted for efficacy following the results of the interim analysis provided for in the protocol on 20 patients.)
First Posted : August 28, 2014
Last Update Posted : April 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia Glioblastoma||Drug: Romiplostim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients|
|Actual Study Start Date :||July 10, 2014|
|Actual Primary Completion Date :||December 14, 2017|
|Actual Study Completion Date :||December 14, 2017|
Romiplostim lyophilized formulation is a white, solide cake that is reconstituted with sterile water for injection.
- Proportion of patients receiving 100% of the planned TMZ dosage in the whole Stupp protocol. The primary endpoint will consider dose reduction and dose delay. [ Time Frame: one year ]
- Incidence of serious adverse events according to CTCAE 4.0 criteria. [ Time Frame: one year ]
- Incidence of delayed chemotherapy cycles and the incidence of chemotherapy cycles with dose reduction due to severe TP [ Time Frame: one year ]
- Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim. [ Time Frame: One year ]
- Number and percentage of patients receiving platelets transfusion for TP [ Time Frame: one year ]
- Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment. [ Time Frame: one year ]
- 6 months Progression Free Survival: [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227576
|CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie|
|Lille, France, 59037 Cedex|
|Hôpital Neurologique Pierre Wertheimer, Lyon,|
|AP-HM,Hôpital La Timone, AP-HM, Marseille|
|AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2|
|Paris, France, 75013|
|Principal Investigator:||Emilie Le Rhun, MD||CHRU Lille|