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

NCT02060955 | Terminated Phase 2 DMC

• 1 other identifier: CV-005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma multiforme; Immunotherapy; Bevacizumab/Irinotecan; ALECSAT; recurrent

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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)

  During the study period up to 62 weeks

Secondary Outcomes (4)

• Overall survival (OS)

  During the study period up to 62 weeks

• Time to progression (TTP)

  During the study period up to 62 weeks

• Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) questionnaire

  During the study period up to 62 weeks

• Overall Response Rate (ORR)

  During the study period up to 62 weeks

Other Outcomes (1)

• Safety & tolerability

  During the study period up to 62 weeks

Study Arms (2)

Alecsat

EXPERIMENTAL

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

bevacizumab/irinotecan

ACTIVE COMPARATOR

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

Interventions

ALECSAT BIOLOGICAL

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.

Also known as: ALECSAT, the investigational product,

Alecsat

Bevacizumab/Irinotecan DRUG

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.

Also known as: Bevacizumab, Irinotecan

bevacizumab/irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CytoVac A/S: lead

Study Sites (4)

Aalborg Universityhospital, Department of Oncology

Aalborg, Hobrovej 18-22, 9000, Denmark

Location

Aarhus University Hospital, Department of Oncology

Aarhus, Nørrebrogade 44, 8000, Denmark

Location

Odense University Hospital, Department of Oncology

Odense, Sdr. Boulevard 29, 5000, Denmark

Location

Department of Oncology, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Martin Roland Jensen, PhD

  CytoVac A/S (Sponsor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

DK (4)