Recruitment

Recruitment Status
Terminated
Estimated Enrollment
175

Inclusion Criteria

Clinically normal Erythrocyte Volume Fraction (EVF)
Adequate performance status equal or below 2
Minimum age of 18 years old,
...
Clinically normal Erythrocyte Volume Fraction (EVF)
Adequate performance status equal or below 2
Minimum age of 18 years old,
Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI,
Expected survival time (life expectancy) of over 3 months
Capable of understanding the information and giving informed consent
Minimum height of 155 cm
Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study

Exclusion Criteria

Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
Inclusion in other clinical studies 4 weeks prior to inclusion in the study
Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
...
Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
Inclusion in other clinical studies 4 weeks prior to inclusion in the study
Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
Clinically abnormal ECG as judged by the Investigator
Clinically significant autoimmune disorders or conditions of immune suppression
Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
Hemoglobin count ≤ 7.5mmol/l (men & women)
Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection
Pregnant or breast feeding women
Body weight below 40 kg (men) and 50 kg (women)
Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombinant humanized antibodies Performance status ≥ 3
Lymphocyte-numbers below 0.5 x 109/l
Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis)
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production
Patients that either may be put at risk due to the blood donation or where it is not expected that an ALECSAT product of good quality can be produced, as judged by the Investigator

Summary

Conditions
Glioblastoma Multiforme
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is an open-label, randomized, prospective, parallel group phase II study with ALECSAT compared to Bevacizumab/Irinotecan in patients with verified relapsed glioblastoma multiforme after or during treatment with recognised first-line treatment. After 62 PFS events have been recorded, an in...

This study is an open-label, randomized, prospective, parallel group phase II study with ALECSAT compared to Bevacizumab/Irinotecan in patients with verified relapsed glioblastoma multiforme after or during treatment with recognised first-line treatment. After 62 PFS events have been recorded, an interim analysis will be conducted under the auspices of the Data Monitoring Committee. The patients in the two treatment groups will be followed for up to 62 weeks by planned study visits. Patients with, at least, stable disease will continue the allocated treatment after the study period as judged by the Investigator. Patients allocated to the Bevacizumab/Irinotecan (control group) will receive their treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle of Bevacizumab/Irinotecan consist of 2 dosing days; day 1 and day 15 in the cycle.

Inclusion Criteria

Clinically normal Erythrocyte Volume Fraction (EVF)
Adequate performance status equal or below 2
Minimum age of 18 years old,
...
Clinically normal Erythrocyte Volume Fraction (EVF)
Adequate performance status equal or below 2
Minimum age of 18 years old,
Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI,
Expected survival time (life expectancy) of over 3 months
Capable of understanding the information and giving informed consent
Minimum height of 155 cm
Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study

Exclusion Criteria

Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
Inclusion in other clinical studies 4 weeks prior to inclusion in the study
Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
...
Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
Inclusion in other clinical studies 4 weeks prior to inclusion in the study
Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
Clinically abnormal ECG as judged by the Investigator
Clinically significant autoimmune disorders or conditions of immune suppression
Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
Hemoglobin count ≤ 7.5mmol/l (men & women)
Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection
Pregnant or breast feeding women
Body weight below 40 kg (men) and 50 kg (women)
Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombinant humanized antibodies Performance status ≥ 3
Lymphocyte-numbers below 0.5 x 109/l
Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis)
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production
Patients that either may be put at risk due to the blood donation or where it is not expected that an ALECSAT product of good quality can be produced, as judged by the Investigator

Tracking Information

NCT #
NCT02060955
Collaborators
Not Provided
Investigators
Study Director: Martin Roland Jensen, PhD CytoVac A/S (Sponsor)
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