View Clinical Trial (Medical Research Study)
Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27710 |
| Conditions: |
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Recurrent Central Nervous System Neoplasm |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00890032 |
| Primary Contact: |
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Principal Investigator
Duane Mitchell, MD, PhD
Duke University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Durham, North Carolina 27710
United States
Denise Lally-Goss, RN, MSN, NP
Phone: 919-684-3862
Email: lally001@mc.duke.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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