Status:
TERMINATED
Prevention of Thrombocytopenia in Glioblastoma Patients
Lead Sponsor:
University Hospital, Lille
Conditions:
Thrombocytopenia
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Chemoth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02227576
Start Date
July 10 2014
End Date
December 14 2017
Last Update
April 25 2018
Active Locations (4)
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1
CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie
Lille, France, 59037 Cedex
2
Hôpital Neurologique Pierre Wertheimer, Lyon,
Lyon, France
3
AP-HM,Hôpital La Timone, AP-HM, Marseille
Marseille, France
4
AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2
Paris, France, 75013