Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma

NCT00846456 | Completed Phase 1 DMC

• 1 other identifier: DC-CAST-GBM
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma; Brain Tumor

Keywords

Tumor setm cell

Outcome Measures

Primary Outcomes (1)

• Adverse events

  During follow-up

Secondary Outcomes (1)

• Evaluation of immunological response, time to disease progression and survival time

  5 years

Interventions

Dendritic cell vaccine with mRNA from tumor stem cells BIOLOGICAL

Intradermal injection of transfected dendritic cells

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Related Publications (1)

• 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.

  PMID: 23817721 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Steinar Aamdal, MD, PhD

  Department of Clinical Cancer Research, Rikshospitalet

  PRINCIPAL INVESTIGATOR

• Iver A Langmoen, MD, PhD

  Dept of Neurosurgery, Ulleval University Hospital

  STUDY DIRECTOR

• Gunnar Kvalheim, MD, PhD

  Dept of cellular therapy, Rikshospitalet HF

  STUDY DIRECTOR

• Gustav Gaudernack, PhD

  Inst. of Immunotherapy, Rikshospitalet HF

  STUDY DIRECTOR

• Knut Lote, MD, PhD

  Dept. of oncology, Rikshospitalet HF

  STUDY DIRECTOR

• Jon Berg-Johnsen, MD, PhD

  Dept. of Neurosurgery, Rikshospitalet HF

  STUDY DIRECTOR

• Carl Langberg, MD, PhD

  Dept of oncology, Ulleval University Hospital

  STUDY DIRECTOR

• Marta Nyakas, MD

  Dept. of Clinical Cancer Research, Rikshospitalet HF

  STUDY DIRECTOR

• Einar O Vik-Mo, MD

  Dept of Neurosurgery, Ulleval University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steinar Aamdal

Study Record Dates

• First Submitted: February 15, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 20, 2015

Record last verified: 2015-10