Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 88 of 1118 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

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 2, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Tracking Information
First Submitted Date  ICMJE October 30, 2009
First Posted Date  ICMJE November 2, 2009
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
Evaluation of the treatment impact on progression-free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01006044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2010)
  • 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
  • Evaluation of impact on other efficiency clinical parameters [ Time Frame: 5 years ]
    1. Overall survival
    2. Quality of life measured with EORTC questionnaire
  • 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)
  • Cell line characterization and correlate the final product with clinical efficacy [ Time Frame: 5 years ]
    a. Phenotypic studies
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Safety evaluation, Direct effects attributable cell obtaining and administration, Adverse events during treatment, Neurological deterioration quantified using the NIH Stroke Scale, Autoimmune phenomena [ Time Frame: 5 years ]
  • Evaluation of impact on other efficiency clinical parameters, Overall survival, Quality of life measured with EORTC questionnaire [ Time Frame: 5 years ]
  • 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) [ Time Frame: 5 years ]
  • Cell line characterization and correlate the final product with clinical efficacy, Phenotypic studies [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Vaccination
Autologous Dendritic cells loaded with tumor lysate
Intervention: Biological: autologous dendritic cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2013)
26
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2009)
37
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01006044
Other Study ID Numbers  ICMJE DEND/GM
2009-009879-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Felipe Prosper, MD, PhD Clinica Universidad de Navarra
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP