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Prevention of Thrombocytopenia in Glioblastoma Patients (PLATUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227576
Recruitment Status : Terminated (Study halted for efficacy following the results of the interim analysis provided for in the protocol on 20 patients.)
First Posted : August 28, 2014
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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. 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.


Condition or disease Intervention/treatment Phase
Thrombocytopenia Glioblastoma Drug: Romiplostim Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients
Actual Study Start Date : July 10, 2014
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim

Arm Intervention/treatment
Experimental: Romiplostim
Romiplostim lyophilized formulation is a white, solide cake that is reconstituted with sterile water for injection.
Drug: Romiplostim



Primary Outcome Measures :
  1. Proportion of patients receiving 100% of the planned TMZ dosage in the whole Stupp protocol. The primary endpoint will consider dose reduction and dose delay. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events according to CTCAE 4.0 criteria. [ Time Frame: one year ]
  2. Incidence of delayed chemotherapy cycles and the incidence of chemotherapy cycles with dose reduction due to severe TP [ Time Frame: one year ]
  3. Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim. [ Time Frame: One year ]
  4. Number and percentage of patients receiving platelets transfusion for TP [ Time Frame: one year ]
  5. Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment. [ Time Frame: one year ]
  6. 6 months Progression Free Survival: [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227576


Locations
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France
CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie
Lille, France, 59037 Cedex
Hôpital Neurologique Pierre Wertheimer, Lyon,
Lyon, France
AP-HM,Hôpital La Timone, AP-HM, Marseille
Marseille, France
AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2
Paris, France, 75013
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Emilie Le Rhun, MD CHRU Lille
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02227576    
Other Study ID Numbers: 2011_29
2012-001751-38 ( EudraCT Number )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
glioblastoma, thrombocytopenia, temozolomide, chemotherapy
Additional relevant MeSH terms:
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Thrombocytopenia
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Blood Platelet Disorders
Hematologic Diseases