Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
This study is currently recruiting participants.
Verified December 2012 by Duke University
Sponsor:
John Sampson
Collaborator:
Information provided by (Responsible Party):
John Sampson, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00890032
First received: April 28, 2009
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Central Nervous System Neoplasm |
Biological: BTSC mRNA-loaded DCs |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Feasibility and safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Humoral and cellular immune responses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 MTD and a DLT.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890032
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Denise Lally-Goss, RN, MSN, NP 919-684-3862 lally001@mc.duke.edu | |
| Contact: Sharon Norman, C.R.C. 919-668-2696 sharon.mcgehee@duke.edu | |
Sponsors and Collaborators
John Sampson
Investigators
| Principal Investigator: | Duane Mitchell, MD, PhD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | John Sampson, Professor of Neurosurgery, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00890032 History of Changes |
| Other Study ID Numbers: | Pro00006677, R01CA135272, P30CA014236, CDR0000630701 |
| Study First Received: | April 28, 2009 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult astrocytoma recurrent adult brain tumor |
Additional relevant MeSH terms:
|
Neoplasms Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma 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 |
ClinicalTrials.gov processed this record on May 16, 2013