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Prevention of Thrombocytopenia in Glioblastoma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02227576
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Emilie Le Rhun, MD
Principal Investigator Affiliation CHRU Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Terminated
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Thrombocytopenia, Glioblastoma
Arms & Interventions

Arms

Experimental: Romiplostim

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

Interventions

Drug: - Romiplostim

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Lille, France

Status

Address

CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie

Lille, , 59037 Cedex

Lyon, France

Status

Address

Hôpital Neurologique Pierre Wertheimer, Lyon,

Lyon, ,

Marseille, France

Status

Address

AP-HM,Hôpital La Timone, AP-HM, Marseille

Marseille, ,

Paris, France

Status

Address

AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2

Paris, , 75013

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