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Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00890032
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : October 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Sampson, Duke University

Brief Summary:

RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).

Condition or disease Intervention/treatment Phase
Recurrent Central Nervous System Neoplasm Biological: BTSC mRNA-loaded DCs Phase 1

Detailed Description:



  • To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
Study Start Date : September 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: BTSC mRNA-loaded DCs
BTSC mRNA-loaded DCs administered intradermally weekly for first 3 vaccines, then monthly until progression or withdrawal.
Biological: BTSC mRNA-loaded DCs
An escalating total dose of BTSC mRNA-loaded DCs (2x10^6, 5x10^6, and 2x10^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).

Primary Outcome Measures :
  1. Feasibility and safety [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Humoral and cellular immune responses [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Karnofsky Performance Status (KPS) of > 70%
  • Radiation Therapy (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-human chorionic gonadotropin (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

Avastin-Specific Exclusion Criteria

Subjects meeting any of the following criteria are ineligible for study entry:

  • Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to enrollment
  • History of stroke or transient ischemic attack within 6 months prior to enrollment
  • Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)
  • History of hemoptysis (> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
  • Serious, non-healing wound, active ulcer or untreated bone fracture
  • Proteinuria as defined by > +1 on urinalysis dipstick
  • Known hypersensitivity to any component of Avastin
  • Pregnant (positive pregnancy test) or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890032

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sampson
National Cancer Institute (NCI)
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Principal Investigator: Gordana Vlahovic, MD Duke University
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Responsible Party: John Sampson, Professor of Neurosurgery, Duke University
ClinicalTrials.gov Identifier: NCT00890032    
Other Study ID Numbers: Pro00006677
R01CA135272 ( U.S. NIH Grant/Contract )
P30CA014236 ( U.S. NIH Grant/Contract )
CDR0000630701 ( Other Identifier: NCI )
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by John Sampson, Duke University:
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult astrocytoma
recurrent adult brain tumor
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases