Clinical trial NCT00846456: Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
Official title: Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Brain Tumor
Keywords: Tumor setm cell
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study induces an immune response towards the stem-cell like part of glioblastomas in combination with standard therapy. The aim is to define and characterize the feasibility, potential adverse effects of such therapy and measure time to progression and survival.


Eligibility criteria: Inclusion Criteria:

* Accessible volume and quality of tumor tissue for vaccine production
* MRI after surgery with minimal tumor remnant.
* Between 18 and 70 years of age.
* Must have histologically confirmed glioma grade IV, and a candidate for combined radiation therapy and chemotherapy ("Stupps regimen").
* Must be ambulatory with a ECOG performance status 0 or 1.
* A minimum 4 weeks must have elapsed between the end of glucocorticoid treatment and beginning of vaccination.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented.

Exclusion Criteria:

* Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on patients neurological condition.
* Large tumor remnant after surgery.
* History of prior malignancy other than glioma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.
* Chronic active infection requiring antibiotic therapy.
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
* Prior splenectomy.
* Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
* Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
* History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis- dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
* Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
* Pregnancy or lactation.
* Any reason why, in the opinion of the investigator, the patient should not participate.

Primary outcomes:
measure: Adverse events
timeFrame: During follow-up
Secondary outcomes:
measure: Evaluation of immunological response, time to disease progression and survival time
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Cancer Research, Rikshospitalet
name: Steinar Aamdal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Neurosurgery, Ulleval University Hospital
name: Iver A Langmoen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept of cellular therapy, Rikshospitalet HF
name: Gunnar Kvalheim, MD, PhD
role: STUDY_DIRECTOR
affiliation: Inst. of Immunotherapy, Rikshospitalet HF
name: Gustav Gaudernack, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of oncology, Rikshospitalet HF
name: Knut Lote, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Neurosurgery, Rikshospitalet HF
name: Jon Berg-Johnsen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept of oncology, Ulleval University Hospital
name: Carl Langberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Clinical Cancer Research, Rikshospitalet HF
name: Marta Nyakas, MD
role: STUDY_DIRECTOR
affiliation: Dept of Neurosurgery, Ulleval University Hospital
name: Einar O Vik-Mo, MD
role: STUDY_DIRECTOR
References:
citation: Vik-Mo EO, Nyakas M, Mikkelsen BV, Moe MC, Due-Tonnesen P, Suso EM, Saeboe-Larssen S, Sandberg C, Brinchmann JE, Helseth E, Rasmussen AM, Lote K, Aamdal S, Gaudernack G, Kvalheim G, Langmoen IA. Therapeutic vaccination against autologous cancer stem cells with mRNA-transfected dendritic cells in patients with glioblastoma. Cancer Immunol Immunother. 2013 Sep;62(9):1499-509. doi: 10.1007/s00262-013-1453-3. Epub 2013 Jul 2.