Prevention of Thrombocytopenia in Glioblastoma Patients

What Was Tested

In this phase 2 trial, researchers set out to test Romiplostim.

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).

It had 1 arm (groups): Romiplostim (experimental).

Romiplostim lyophilized formulation is a white, solide cake that is reconstituted with sterile water for injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histological proof of newly diagnosed glioblastoma,. Age: 18 and older,. Information to patient and signed consent form,. Indication for a " Stupp " protocol (cerebral focal radiotherapy and concomitant TMZ followed by adjuvant TMZ - 6 cycles),. Normal initial platelets count (\> 100 000/mm3) before the start of Temozolomide during the RT/CT concomitant phase,.

The full record lists 12 inclusion and 17 exclusion criteria; among the exclusions: concomitant radiotherapy (romiplostim will be started after the completion of the rt/ct concomitant phase),; other malignancies (prior hx malignancies),; any anterior systemic chemotherapy,.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-07-10 with completion listed for 2017-12-14.

It ran at 4 sites in France (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Incidence of serious adverse events according to CTCAE 4.0 criteria, Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim, Number and percentage of patients receiving platelets transfusion for TP, Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment and 6 months Progression Free Survival:.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 20 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.