Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Glioblastoma Multiforme

Thank you

Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the treatment impact on progression-free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Felipe Prosper, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Clinica Universidad de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

DEND/GM

NCT ID:

NCT01006044

Start Date:

October 2009

Completion Date:

June 2014

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma multiforme, vaccine, dendritic cells, glioma
  • Glioblastoma

Name

Location