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Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan

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ClinicalTrials.gov Identifier: NCT02060955
Recruitment Status : Terminated (Substantial design modifications required.)
First Posted : February 12, 2014
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
CytoVac A/S

Brief Summary:
The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Biological: ALECSAT Drug: Bevacizumab/Irinotecan Phase 2

Detailed 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 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: Alecsat

The experimental product is an autologous product based on the individual patients blood. Blood donation are performed in study weeks 0, 6, 11, 23 and 43.

The patient receives treatment as bolus injection at study weeks 4, 9, 14, 26 and 46.

Biological: ALECSAT
The ALECSAT will be administered at week 4, 9, 14, 26 and week 46. Cells are re-suspended in a plasmalyte injection fluid up to a total volume of 20 ml. The 20 ml cell suspension will contain between 10 million and 1 billion cells. Each dose is supplied in a sterile 20 ml syringe and should be injected intravenously.
Other Name: ALECSAT, the investigational product,

Active Comparator: bevacizumab/irinotecan
Patients allocated to the comparator arm will be treated in accordance with standard practice in Denmark for relapsed glioblastoma multiforme, up to 16 treatment cycles with 4 weeks duration
Drug: Bevacizumab/Irinotecan
Patients allocated to the Bevacizumab/Irinotecan (control group) will receive treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle consist of 2 dosing days; day 1 and day 15 in the cycle.
Other Names:
  • Bevacizumab
  • Irinotecan




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: During the study period up to 62 weeks ]
    To compare progression-free survival (PFS) in patients with relapsed GBM when the patients are either treated with ALECSAT immunotherapy or standard praxis therapy with Bevacizumab/Irinotecan. Progression of disease is defined according to the response evaluation criteria for solid tumours (RANO)


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: During the study period up to 62 weeks ]
    To evaluate the overall survival (OS) during the study period in patients treated with ALECSAT compared to patients treated with Bevacizumab/Irinotecan by Kaplan-Meier methodology

  2. Time to progression (TTP) [ Time Frame: During the study period up to 62 weeks ]
    To evaluate time to progression in the two treatment groups To compare PFS in the two treatment groups by Kaplan-Meier methodology upon study completion To compare PFS in a landmark analysis in the two treatment groups after a duration of 6 and 12 months after initiation of treatment

  3. Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) questionnaire [ Time Frame: During the study period up to 62 weeks ]
    To investigate QoL and performance status during the study period for patients treated with ALECSAT compared to patients treated with Avastin/Irinotecan

  4. Overall Response Rate (ORR) [ Time Frame: During the study period up to 62 weeks ]
    To compare Objective Response Rate (ORR)


Other Outcome Measures:
  1. Safety & tolerability [ Time Frame: During the study period up to 62 weeks ]
    Comparison of type and frequency of AEs; changes in biochemical parameters of clinical relevance; in hematology parameters of clinical relevance; in vital signs and change in electrocardiogram (ECG). Evaluation of medical events of special interest.



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:

  • Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI,
  • Minimum age of 18 years old,
  • Capable of understanding the information and giving informed consent
  • Minimum height of 155 cm
  • Expected survival time (life expectancy) of over 3 months
  • Adequate performance status equal or below 2
  • Clinically normal Erythrocyte Volume Fraction (EVF)
  • 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:

  • Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis)
  • 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
  • Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
  • Clinically significant autoimmune disorders or conditions of immune suppression
  • Hemoglobin count ≤ 7.5mmol/l (men & women)
  • Lymphocyte-numbers below 0.5 x 109/l
  • Body weight below 40 kg (men) and 50 kg (women)
  • Clinically abnormal ECG as judged by the Investigator
  • Pregnant or breast feeding women
  • 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
  • Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
  • 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
  • Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection
  • Blood transfusions within 48 hours prior to donation of blood for ALECSAT production
  • Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombinant humanized antibodies Performance status ≥ 3

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): NCT02060955


Locations
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Denmark
Aalborg Universityhospital, Department of Oncology
Aalborg, Hobrovej 18-22, Denmark, 9000
Aarhus University Hospital, Department of Oncology
Aarhus, Nørrebrogade 44, Denmark, 8000
Odense University Hospital, Department of Oncology
Odense, Sdr. Boulevard 29, Denmark, 5000
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
CytoVac A/S
Investigators
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Study Director: Martin Roland Jensen, PhD CytoVac A/S (Sponsor)

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Responsible Party: CytoVac A/S
ClinicalTrials.gov Identifier: NCT02060955     History of Changes
Other Study ID Numbers: CV-005
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by CytoVac A/S:
Glioblastoma multiforme
Immunotherapy
Bevacizumab/Irinotecan
ALECSAT
recurrent

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action