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

NCT01006044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-09-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Felipe Prosper, MD, PhD · Clinica Universidad de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006044 on ClinicalTrials.gov