Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
18 Years
N/A
Both
Recurrent Central Nervous System Neoplasm
Trial Information
Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
OBJECTIVES:
Primary
- To evaluate the feasibility and safety of an autologous brain tumor stem cell
mRNA-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma
multiforme.
Secondary
- To assess humoral and cellular immune responses to vaccination.
- To compare the proportion of vaccinated patients alive at 6 months from the time of
surgery for recurrent tumor with matched historical cohorts.
OUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to
isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific
mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours
to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the
third vaccination and then at least every 3 months as needed for generation of additional
DCs.
Patients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3
weeks and then once monthly in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Inclusion Criteria:
- Age >18 years of age
- First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible
areas with prior histologic diagnosis of GBM
- No known contraindications to receiving Avastin
- KPS of > 70%
- RT with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry
Exclusion Criteria:
- Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor
dissemination (subependymal or leptomeningeal)
- Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment
- Pregnant or need to breast feed during the study period (Negative beta-HCG test
required), or unable to maintain use of contraception while on study
- Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F)
illness
- Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus
infection, Hepatitis B or Hepatitis C
- Unstable or severe intercurrent medical conditions such as severe heart (New York
Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes
mellitus
- Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or
stereotactic radiosurgery
- Prior inguinal lymph node dissection
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility and safety
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Gordana Vlahovic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University
Authority:
United States: Food and Drug Administration
Study ID:
Pro00006677
NCT ID:
NCT00890032
Start Date:
September 2009
Completion Date:
September 2015
Related Keywords:
- Recurrent Central Nervous System Neoplasm
- adult giant cell glioblastoma
- adult glioblastoma
- adult gliosarcoma
- adult astrocytoma
- recurrent adult brain tumor
- Neoplasms
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Duke University Medical Center | Durham, North Carolina 27710 |
