Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02227576 : Prevention of Thrombocytopenia in Glioblastoma Patients
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02227576      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740