Prevention of Thrombocytopenia in Glioblastoma Patients (PLATUM)

This is an interventional treatment trial for Thrombocytopenia focused on measuring glioblastoma, thrombocytopenia, temozolomide, chemotherapy Read More

Inclusion Criteria:

• 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),
• Patient with grade 3 or 4 TP during Temozolomide chemotherapy, regardless of when the onset of TP was: after completion of concomitant RT/CT, before adjuvant CT or during adjuvant CT and only if a minimum of 2 cycles are still planned,
• Normal initial platelets count (> 100 000/mm3) before the start of Temozolomide during the RT/CT concomitant phase,
• Adequate haematological, renal, hepatic function at the time of inclusion visit,
• ECOG PS 0-2 (patients unable to walk because of a paralysis and who are up in a wheel chair will be considered as ambulatory for the evaluation of the ECOG performance status),
• Life expectancy > 2 months,
• Patients covered by the French Health Insurance System,
• Negative pregnancy test at the time of inclusion visit,
• If required, effective contraception respecting criteria of CPMP/ICH/286/95 (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).

Exclusion Criteria:

• Concomitant radiotherapy (Romiplostim will be started after the completion of the RT/CT concomitant phase),
• Other malignancies (prior hx malignancies),
• Any anterior systemic chemotherapy,
• Any known coagulation disease or known haematological disease even if resolved. Known hypercoagulate state (e.g., factor V Leiden, protein C defiency, protein S deficiency, PT 20201, antiphospholipid antibody syndrome…),
• Prior Romiplostim exposure or prior exposure to other TPO mimetics,
• History of thromboembolic disease < 6 months. Treatment with anticoagulant such as Heparin or antivitamin K (LMWH as prophylactic treatment is authorized),
• Any other hemato-toxicity (anemia, neutropenia) requiring EPO or GCSF,
• Other causes of Temozolomide interruption (non haematological toxicities),
• Known hypersensitivity to any E-coli derived product,
• Participation to any other study during the last 30 days,
• Refusal to give written informed consent,
• Pregnancy or nursing,
• For all men and women of childbearing potential: Refusal or inability to use effective means of contraception,
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
• Persons protected by a legal regime (guardianship, trusteeship),
• Patients in emergency situations,
• Patients kept in detention.