NCT01588769

Brief Summary

It is the primary objective of this study to show safety and tolerability for administration of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a secondary objective to establish if any indications of positive therapeutic or palliative effects may be observed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

April 27, 2012

Last Update Submit

June 3, 2016

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma MultiformeBrain cancerImmunotherapyCell based therapyAutologous cell based therapyAdoptive immunotherapyCytotoxic T cellsNatural Killer cells

Outcome Measures

Primary Outcomes (1)

  • Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.

    3 months

Secondary Outcomes (1)

  • Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain.

    3 months

Study Arms (1)

One arm

EXPERIMENTAL

3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients

Biological: ALECSAT cell based immunotherapy

Interventions

ALECSAT cell based immunotherapyBIOLOGICAL

I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.

One arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment.
  • Be over the age of 18 and capable of understanding the information and giving informed consent.
  • Adequate performance status \> 50% (see below\*).
  • Performance is monitored according to the Karnofsky Performance Score (KPS)
  • % - normal, no complaints, no signs of disease
  • % - capable of normal activity, few symptoms or signs of disease
  • % - normal activity with some difficulty, some symptoms or signs
  • % - caring for self, not capable of normal activity or work
  • % - requiring some help, can take care of most personal requirements
  • % - requires help often, requires frequent medical care
  • % - disabled, requires special care and help
  • % - severely disabled, hospital admission indicated but no risk of death
  • % - very ill, urgently requiring admission, requires supportive measures or treatment
  • % - moribund, rapidly progressive fatal disease processes
  • % - death.

You may not qualify if:

  • A low blood count (haemoglobin \< 6.0 mmol/l).
  • Lymphocyte counts below 0.8 x 109/l.
  • Positive tests for anti-HIV-1/2;
  • Positive tests for HBsAg,
  • Positive tests for anti-HBc and Anti-HCV.
  • Syphilis i.e. being positive in a Treponema Pallidum test.
  • Uncontrolled serious bacterial, viral, fungal or parasitic infection.
  • Clinically significant autoimmune disorders or conditions of immune suppression.
  • Pregnant women cannot be included in the trial. Fertile women can only be included with a negative pregnancy test and must use contraceptives during the study.
  • Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
  • The patient's medical condition is evaluated to be so poor that there is a significant risk for the patient to be part of the trial and to evaluate any effects of the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Rigshospitalet

Copenhagen, DK 2100, Denmark

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Martin R Jensen, PhD

    CytoVac A/S (Sponsor)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 1, 2012

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

DK(1)