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Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01006044
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Description
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Brief Summary:

  1. Primary outcome measure:

    a.Evaluation of the treatment impact on progression-free survival.

  2. Secondary outcome measures:

    1. Safety evaluation.

      • Direct effects attributable cell obtaining and administration.
      • Adverse events during treatment.
      • Neurological deterioration quantified using the NIH Stroke Scale.
      • Autoimmune phenomena.

    2. Evaluation of impact on other efficiency clinical parameters.

      • Overall survival.
      • Quality of life measured with EORTC questionnaire.

    3. Study of specific immune response and correlates with clinical outcome.

      • Delayed hypersensitivity.
      • Humoral response to autologous tumor cells/tumoral lysate.
      • Cellular response (proliferation, cytokine production, specific cytotoxicity).

    4. Cell line characterization and correlate the final product with clinical efficacy.

      • Phenotypic studies.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Biological: autologous dendritic cells Phase 2

Detailed Description:

A prospective, open-label, unicentric phase II trial, historical control and non-randomized.

The study will try to evaluate the efficiency and safety of the experimental treatment using a cell therapy product (tumor lysate-pulsed autologous dendritic cell vaccine) in patients with glioblastoma multiforme in whom a gross total resection is feasible. Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope
Study Start Date : October 2009
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccination
Autologous Dendritic cells loaded with tumor lysate
 Biological: autologous dendritic cells
Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the treatment impact on progression-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Safety evaluation [ Time Frame: 5 years ]
    1. Direct effects attributable cell obtaining and administration
    2. Adverse events during treatment
    3. Neurological deterioration quantified using the NIH Stroke Scale
    4. Autoimmune phenomena

  2. Evaluation of impact on other efficiency clinical parameters [ Time Frame: 5 years ]
    1. Overall survival
    2. Quality of life measured with EORTC questionnaire

  3. Study of specific immune response and correlates with clinical outcome [ Time Frame: 5 years ]
    1. Delayed hypersensitivity
    2. Humoral response to autologous tumor cells/tumoral lysate
    3. Cellular response (proliferation, cytokine production, specific cytotoxicity)

  4. Cell line characterization and correlate the final product with clinical efficacy [ Time Frame: 5 years ]
    a. Phenotypic studies


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histological diagnosis of glioblastoma that have not received any previous chemotherapy or radiotherapy treatment.
  • Patients are able to give informed consent and willing to comply with the protocol requirements during the study period.
  • Age between 18 and 70 years
  • Negative pregnancy test In female fertile subjects
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Complete/Total resection of tumour with surgery guided by fluorescence microscopy and 5-aminolevulinic acid, observed with post operative magnetic resonance imaging. The residual lesion must be null or ≤ 1 cm3 by contrast capturing.
  • Enough tumor tissue available for the cellular vaccine elaboration

Exclusion Criteria:

  • Patients with infections, severe diseases or hepatic, renal or medullary failures, that in the investigator's opinion, are not eligible to participate in the study.
  • Participation in other clinical trial. If the patient has participated in other clinical trial within previous months, the patient has to complete the washout period required by de the investigator.
  • Patients with diagnosis of other neoplasia, except basal cell or squamous cell skin, carcinoma in situ of the cervix properly treated or other tumour curatively treated and no evidence of relapse for at least 3 years. Those cases with coexisting tumours of long-term survival prediction will be considered individually.
  • Pregnant or breast-feeding women.
  • Patients who need immunosuppressive drugs.
  • Positive serology for HIV , hepatitis B (HBsAg) or hepatitis C virus.
  • Impossible to get enough material for at least 6 cellular vaccine production.
  • Absolute contraindication for the patient to receive other steps of standard treatment of glioblastoma (surgery, radio and chemotherapy)
Contacts and Locations
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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): NCT01006044


Locations
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Spain
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Study Director: Felipe Prosper, MD, PhD Clinica Universidad de Navarra
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01006044    
Other Study ID Numbers: DEND/GM
2009-009879-35 ( EudraCT Number )
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Glioblastoma multiforme, vaccine, dendritic cells, glioma
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