A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients (ALECSAT-GBM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoVac A/S
ClinicalTrials.gov Identifier:
NCT01588769
First received: April 27, 2012
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme
Biological: ALECSAT cell based immunotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Investigate Tolerability and Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-cells (ALECSAT) Administered to Patients With Glioblastoma Multiforme (GBM)

Resource links provided by NLM:


Further study details as provided by CytoVac A/S:

Primary Outcome Measures:
  • Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A total of 4 scanannings are performed during the study: 2 PET-MRI scans and 2 SPECT (Single-photon emission computed tomography) scans.


Enrollment: 23
Study Start Date: August 2011
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: ALECSAT cell based immunotherapy
    I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.
Detailed Description:

The primary objective for this study is to establish if any side effects or toxicity issues occur, that will prevent further clinical development of the autologous cell based immunotherapy ALECSAT in Glioblastoma (GBM) or to establish if there are side effects or toxicity issues, that will suggest that the further clinical development planned, has to change course significantly. It is a primary objective to show safety and tolerability for administration of ALECSAT, thus not meeting this endpoint, may stop further clinical development of ALECSAT.

The secondary objective for this study is to establish if any indications of a positive therapeutic or palliative effect may be observed. As this is a secondary objective, no observed significant positive clinical effect, will not prevent further clinical development or in itself, trigger changes in the further clinical development planned.

The overall endpoint of the study is to develop a new therapeutic approach that may slow down or stop disease progression in late stage GBM patients.

ALECSAT is an autologous cell based immunotherapy based on the patient's own Natural Killer cells and CytoToxic T cells. The cells are isolated from the patient's own blood - activated and expanded in number before re administering i. v.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment.
  2. Be over the age of 18 and capable of understanding the information and giving informed consent.
  3. Adequate performance status > 50% (see below*).

    • Performance is monitored according to the Karnofsky Performance Score (KPS)

      • 100% - normal, no complaints, no signs of disease
      • 90% - capable of normal activity, few symptoms or signs of disease
      • 80% - normal activity with some difficulty, some symptoms or signs
      • 70% - caring for self, not capable of normal activity or work
      • 60% - requiring some help, can take care of most personal requirements
      • 50% - requires help often, requires frequent medical care
      • 40% - disabled, requires special care and help
      • 30% - severely disabled, hospital admission indicated but no risk of death
      • 20% - very ill, urgently requiring admission, requires supportive measures or treatment
      • 10% - moribund, rapidly progressive fatal disease processes
      • 0% - death.

Exclusion Criteria:

  1. A low blood count (haemoglobin < 6.0 mmol/l).
  2. Lymphocyte counts below 0.8 x 109/l.
  3. Positive tests for anti-HIV-1/2;
  4. Positive tests for HBsAg,
  5. Positive tests for anti-HBc and Anti-HCV.
  6. Syphilis i.e. being positive in a Treponema Pallidum test.
  7. Uncontrolled serious bacterial, viral, fungal or parasitic infection.
  8. Clinically significant autoimmune disorders or conditions of immune suppression.
  9. Treatment with chemotherapy three weeks prior to inclusion in the clinical trial.
  10. 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.
  11. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
  12. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial.
  13. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588769

Locations
Denmark
Department of Neurosurgery, Rigshospitalet
Copenhagen, Denmark, DK 2100
Sponsors and Collaborators
CytoVac A/S
Investigators
Study Director: Martin R Jensen, PhD CytoVac A/S (Sponsor)
  More Information

Additional Information:
No publications provided

Responsible Party: CytoVac A/S
ClinicalTrials.gov Identifier: NCT01588769     History of Changes
Other Study ID Numbers: CV003, 2011-002180-22
Study First Received: April 27, 2012
Last Updated: April 4, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by CytoVac A/S:
Glioblastoma Multiforme
Brain cancer
Immunotherapy
Cell based therapy
Autologous cell based therapy
Adoptive immunotherapy
Cytotoxic T cells
Natural Killer cells

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014