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Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Recurrent Central Nervous System Neoplasm

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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