Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma

NCT01022918

Last updated date
Study Location
Centre Georges François Leclerc
Dijon, Bourgogne, 21000, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Naive Unresectable Glioblastoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All the eligibility criteria must be met before registration :

- delay upper or equal to 14 days from stereotaxic biopsy and 28 days from surgical biopsy

- Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)

- Patient belonging to the RPA V class or associated

- only supratentorial glioblastoma

- Diagnosis must be obtained by a stereotactic or surgical biopsy

- Age between 18 and 70

- A contrast-enhanced MRI must be performed within 28 days prior to study registration

- Total or partial surgical resection deemed as not possible by a neurosurgeon

- Karnofsky Index (KI) performance status over 50

- Life expectancy of at least 3 months

- A stable dose of corticosteroid for at least 7 days to control intracranial pressure and neurological symptoms

- Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets; hemoglobin > 10 g/dl after blood transfusion if required

- Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 2.5 ULN, Prothrombin rate > 75 %

- Adequate renal function: creatinine < 1.2 ULN; proteinuria test 0 or trace (or urine protein concentration < 1g/24h if proteinuria test is + or ++).

- Negative pregnancy test for women of childbearing potential and adequate contraception for men and women.

- systolic arterial blood pressure at rest ≤ 170 mmHg

- Patient must have been informed and must have signed the specific informed consent form.

- holder of a coverage by the health insurance

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- patient belonging to the RPA III or IV


- prior malignant tumor in the recent 5 years or concomitant malignancy


- prior anti-tumoral chemotherapy or radiotherapy


- prior gross resection of the brain tumor


- patient receiving gliadel


- cardiovascular contra-indications to bevacizumab : prior angina pectoris, prior
myocardial infarction, prior brain stroke, even transient, distal severe arteriopathy,
uncontrolled high blood pressure


- anticomitial drug p450 cytochrome inductors


- other substances inducing p450 cytochrome


- proteinuria ≥ 1g/L


- concurrent anticoagulant or platelet anti-aggregant treatment


- congenital haemorrhagic pathology (haemophilia, Willebrandt)


- sign of brain haemorrhage on the RMI initial exam


- non resolved infectious disease


- non controlled arterial hypertension (≥170 mmHg)


- intracranial high pressure not controlled by a stable dose of steroids for at least 7
days


- pregnancy or refusal of the contraception for women and men


- psychiatric, behavioural disorders or geographical situation precluding the
administration or follow-up of the protocol (including claustrophobia)


- digestive haemorrhage and / or gastro-duodenal ulcer occurring in the last 3 months


- pregnant, nursing woman, or without contraception


- private individuals of freedom or under tutelage (including legal guardianship)

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Naive Unresectable GlioblastomaEvaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma
NCT01022918
  1. Dijon, Bourgogne
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma
Official Title  ICMJE Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide
Brief Summary

Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month median survival, in the range of the comparable patients in the RPA class V from the EORTC study (Miramanoff, 2006).

Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully published in J Clin Oncol, 2007) a 57 % unexpected response rate using a bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This unusual high response rate, sometimes with major and sustained responses, was confirmed by a cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.

The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the Duke University. We believe that an ambitious comparison of the bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a fascinating challenge to improve the treatment of this awful disease.

The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant and adjuvant treatment of chemoradiation with temozolomide for naive unresectable glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France) through its research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of this program is now starting .

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Naive Unresectable Glioblastoma
Intervention  ICMJE
  • Drug: Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures)
  • Drug: Temodal/radiotherapy
Study Arms  ICMJE
  • Experimental: Bevacizumab/Irinoecan

    Neoadjuvant Treatment Patient will receive bevacizumab 10mg/kg plus irinotecan 125mg/m² 4 times every two weeks.

    Radiochemotherapy Then they will receive conformational radiotherapy for 6 weeks (30 Gy, 2Gy/fractions) associated with Temodal ( 75mg/m²/day) from first day up to the end of radiotherapy and 4 injections of Avastin (15mg/kg Day 1, day 15, day 29 and day 43).

    Adjuvant treatment:

    Patients will receive bevacizumab 15mg/kg plus irinotecan 125mg/m² 12 times every two weeks.

    Intervention: Drug: Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures)
  • Active Comparator: Stupp
    patient will receive 6 weeks chemotherapy treatment associating conformational 30 Gy (2Gy/ fraction)and Temodal(75mg/m²/day, followed by 6 months adjuvant therapy consisting in 5 days every 28 days of Temodal (150-200mg/m².
    Intervention: Drug: Temodal/radiotherapy
Publications * Chauffert B, Feuvret L, Bonnetain F, Taillandier L, Frappaz D, Taillia H, Schott R, Honnorat J, Fabbro M, Tennevet I, Ghiringhelli F, Guillamo JS, Durando X, Castera D, Frenay M, Campello C, Dalban C, Skrzypski J, Chinot O. Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared with temozolomide-chemoradiation for unresectable glioblastoma: final results of the TEMAVIR study from ANOCEF?. Ann Oncol. 2014 Jul;25(7):1442-1447. doi: 10.1093/annonc/mdu148. Epub 2014 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
134
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All the eligibility criteria must be met before registration :

  • delay upper or equal to 14 days from stereotaxic biopsy and 28 days from surgical biopsy
  • Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
  • Patient belonging to the RPA V class or associated
  • only supratentorial glioblastoma
  • Diagnosis must be obtained by a stereotactic or surgical biopsy
  • Age between 18 and 70
  • A contrast-enhanced MRI must be performed within 28 days prior to study registration
  • Total or partial surgical resection deemed as not possible by a neurosurgeon
  • Karnofsky Index (KI) performance status over 50
  • Life expectancy of at least 3 months
  • A stable dose of corticosteroid for at least 7 days to control intracranial pressure and neurological symptoms
  • Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets; hemoglobin > 10 g/dl after blood transfusion if required
  • Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 2.5 ULN, Prothrombin rate > 75 %
  • Adequate renal function: creatinine < 1.2 ULN; proteinuria test 0 or trace (or urine protein concentration < 1g/24h if proteinuria test is + or ++).
  • Negative pregnancy test for women of childbearing potential and adequate contraception for men and women.
  • systolic arterial blood pressure at rest ? 170 mmHg
  • Patient must have been informed and must have signed the specific informed consent form.
  • holder of a coverage by the health insurance

Exclusion Criteria:

  • patient belonging to the RPA III or IV
  • prior malignant tumor in the recent 5 years or concomitant malignancy
  • prior anti-tumoral chemotherapy or radiotherapy
  • prior gross resection of the brain tumor
  • patient receiving gliadel
  • cardiovascular contra-indications to bevacizumab : prior angina pectoris, prior myocardial infarction, prior brain stroke, even transient, distal severe arteriopathy, uncontrolled high blood pressure
  • anticomitial drug p450 cytochrome inductors
  • other substances inducing p450 cytochrome
  • proteinuria ? 1g/L
  • concurrent anticoagulant or platelet anti-aggregant treatment
  • congenital haemorrhagic pathology (haemophilia, Willebrandt)
  • sign of brain haemorrhage on the RMI initial exam
  • non resolved infectious disease
  • non controlled arterial hypertension (?170 mmHg)
  • intracranial high pressure not controlled by a stable dose of steroids for at least 7 days
  • pregnancy or refusal of the contraception for women and men
  • psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
  • digestive haemorrhage and / or gastro-duodenal ulcer occurring in the last 3 months
  • pregnant, nursing woman, or without contraception
  • private individuals of freedom or under tutelage (including legal guardianship)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022918
Other Study ID Numbers  ICMJE TemAvIr
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor  ICMJE Centre Georges Francois Leclerc
Collaborators  ICMJE
  • National Cancer Institute, France
  • Association de Neuro-Oncologues d'Expression Francaise
  • UNICANCER
  • Hoffmann-La Roche
  • Pfizer
Investigators  ICMJE
Principal Investigator:Bruno Chauffert, ProfessorCentre Hospitalier Universitaire, Amiens
PRS Account Centre Georges Francois Leclerc
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP