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Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy (SPECTROBEVA)

Primary Purpose

Glioblastoma, Radiotherapy, Chemotherapy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Analysis of spectroscopic biomarkers of proliferation for six-month survival
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy

  • Biological Criteria

    • Polymorphonuclear neutrophils> 1500 / mm3
    • Plates> 100,000 / mm3
    • SGOT-SGPT <5 at the upper limit of normal (ULN)
    • Bilirubin <1.5 x ULN
    • Creatinine <1.5 LSN and creatinine clearance
    • Proteinuria <1 g / 24 hours
    • Patient with health insurance
    • Consent signed by the patient if he is lucid, or failing that by the person of trust

Exclusion Criteria:

  • Patients who can not benefit from bevacizumab for the following reasons:

    • Symptomatic cerebral or tumor hemorrhage
    • Karnofsky Index less than 50% or
  • Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence).
  • Coagulation disorders in case of injectable treatment (especially for avastin),
  • Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ...
  • Uncontrolled severe concomitant pathology, including another evolving cancer (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated).
  • Uncontrolled Infection
  • Uncontrolled hypertension (PAS> 160 mm Hg) despite optimized treatment
  • Coronary artery disease or unstable arterial disease. Evolutionary aneurysm.
  • Myocardial infarction dating from less than 6 months.
  • Peripheral arterial or cerebrovascular accident occurring less than 6 months.
  • Heart Failure> grade II NYHA
  • Hemorrhagic Disease (Hemophilia, Willebrandt ...)
  • Nephrotic syndrome with proteinuria> 2 g / 24 h
  • History of haemoptysis dating less than 1 month.
  • Pulmonary embolism dating less than 1 month.
  • Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery.
  • History of digestive fistula or intestinal perforation with resolution less than 6 months.
  • Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition.
  • Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies.
  • Severe Myelosuppression
  • Pregnant or nursing. Contraception should be prescribed if necessary during treatment.
  • Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship),
  • Subject involved in another search including an exclusion period still in progress at pre-inclusion
  • Patient refusing to participate in the study

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients, aged 18-88, with glioblastoma

Arm Description

Outcomes

Primary Outcome Measures

Analyze 6-month survival defined as the time between inclusion in the protocol and death

Secondary Outcome Measures

Full Information

First Posted
April 27, 2017
Last Updated
July 19, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03144167
Brief Title
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Acronym
SPECTROBEVA
Official Title
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Anticipated)
Primary Completion Date
January 20, 2021 (Anticipated)
Study Completion Date
January 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment. These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients, aged 18-88, with glioblastoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Analysis of spectroscopic biomarkers of proliferation for six-month survival
Intervention Description
Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival
Primary Outcome Measure Information:
Title
Analyze 6-month survival defined as the time between inclusion in the protocol and death
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy Biological Criteria Polymorphonuclear neutrophils> 1500 / mm3 Plates> 100,000 / mm3 SGOT-SGPT <5 at the upper limit of normal (ULN) Bilirubin <1.5 x ULN Creatinine <1.5 LSN and creatinine clearance Proteinuria <1 g / 24 hours Patient with health insurance Consent signed by the patient if he is lucid, or failing that by the person of trust Exclusion Criteria: Patients who can not benefit from bevacizumab for the following reasons: Symptomatic cerebral or tumor hemorrhage Karnofsky Index less than 50% or Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence). Coagulation disorders in case of injectable treatment (especially for avastin), Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ... Uncontrolled severe concomitant pathology, including another evolving cancer (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated). Uncontrolled Infection Uncontrolled hypertension (PAS> 160 mm Hg) despite optimized treatment Coronary artery disease or unstable arterial disease. Evolutionary aneurysm. Myocardial infarction dating from less than 6 months. Peripheral arterial or cerebrovascular accident occurring less than 6 months. Heart Failure> grade II NYHA Hemorrhagic Disease (Hemophilia, Willebrandt ...) Nephrotic syndrome with proteinuria> 2 g / 24 h History of haemoptysis dating less than 1 month. Pulmonary embolism dating less than 1 month. Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery. History of digestive fistula or intestinal perforation with resolution less than 6 months. Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition. Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies. Severe Myelosuppression Pregnant or nursing. Contraception should be prescribed if necessary during treatment. Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship), Subject involved in another search including an exclusion period still in progress at pre-inclusion Patient refusing to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc CONSTANS, PhD
Phone
+33322087511
Email
constans.jean-marc@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc CONSTANS, PhD
Phone
+33322087511
Email
constans.jean-marc@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

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