Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan
Last updated on April 2022Recruitment
- 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)