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

NCT01006044 | Completed Phase 2

• 2 other identifiers: DEND/GM2009-009879-35
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

• Direct effects attributable cell obtaining and administration.
• Adverse events during treatment.
• Neurological deterioration quantified using the NIH Stroke Scale.
• Autoimmune phenomena.
• Evaluation of impact on other efficiency clinical parameters.
• Overall survival.
• Quality of life measured with EORTC questionnaire.
• 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).
• Cell line characterization and correlate the final product with clinical efficacy.
• Phenotypic studies.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma multiforme, vaccine, dendritic cells, glioma

Outcome Measures

Primary Outcomes (1)

• Evaluation of the treatment impact on progression-free survival

  5 years

Secondary Outcomes (4)

• Safety evaluation

  5 years

• Evaluation of impact on other efficiency clinical parameters

  5 years

• Study of specific immune response and correlates with clinical outcome

  5 years

• Cell line characterization and correlate the final product with clinical efficacy

  5 years

Study Arms (1)

Vaccination

EXPERIMENTAL

Autologous Dendritic cells loaded with tumor lysate

Biological: autologous dendritic cells

Interventions

autologous dendritic cells BIOLOGICAL

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.

Vaccination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Related Publications (4)

• Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24. doi: 10.3171/jns.1999.90.6.1115.

  PMID: 10350260 BACKGROUND

• Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

• Omuro AM, Faivre S, Raymond E. Lessons learned in the development of targeted therapy for malignant gliomas. Mol Cancer Ther. 2007 Jul;6(7):1909-19. doi: 10.1158/1535-7163.MCT-07-0047.

  PMID: 17620423 BACKGROUND

• Inoges S, Tejada S, de Cerio AL, Gallego Perez-Larraya J, Espinos J, Idoate MA, Dominguez PD, de Eulate RG, Aristu J, Bendandi M, Pastor F, Alonso M, Andreu E, Cardoso FP, Valle RD. A phase II trial of autologous dendritic cell vaccination and radiochemotherapy following fluorescence-guided surgery in newly diagnosed glioblastoma patients. J Transl Med. 2017 May 12;15(1):104. doi: 10.1186/s12967-017-1202-z.

  PMID: 28499389 DERIVED

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Felipe Prosper, MD, PhD

  Clinica Universidad de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

ES (1)