Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme - Full Text View

Sponsor:	Duke University
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Duke University
ClinicalTrials.gov Identifier:	NCT00890032

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
Brain and Central Nervous System Tumors	Biological: autologous CD133-positive BTSC mRNA-pulsed autologous dendritic cell vaccine Procedure: adjuvant therapy Procedure: therapeutic conventional surgery	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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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)

Intervention Details:

An escalating total dose of mRNA-loaded DCs (2x10^6, 5x10^6, and 2x10^7 per vaccination) will be evaluated for purpose of establishing a MTD and a DLT.

Avastin

Surgical resection of recurrent brain tumor.

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

DISEASE CHARACTERISTICS:

Histologically confirmed glioblastoma multiforme
- Disease in first recurrence
Surgically accessible disease
Completed radiotherapy with ≥ 45 Gy tumor dose ≥ 8 weeks prior to study entry
None of the following:
- Contrast-enhancing tumor components crossing the midline
- Multi-focal tumor
- Tumor dissemination (subependymal or leptomeningeal)
- Clinically significant increased intracranial pressure (e.g., impending herniation)
- Uncontrolled seizures
- Requirement for immediate palliative treatment

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No unstable or severe concurrent medical condition (e.g., NYHA class III or IV heart disease, lung disease [i.e., FEV_1 < 50%], or uncontrolled diabetes mellitus)
No active infection requiring treatment
No unexplained febrile (> 101.5° F) illness
No known immunosuppressive disease, autoimmune disease, HIV infection, or hepatitis B or C infection
No known contraindications to bevacizumab (Avastin)
No requirement for corticosteroids above physiologic levels (e.g., dexamethasone > 2 mg/day) at the time of first vaccine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery
No prior inguinal lymph node dissection
No prior bevacizumab (Avastin)

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

Duke University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Duane Mitchell, MD, PhD

Duke University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00890032 History of Changes
Other Study ID Numbers:	CDR0000630701, R01CA135272, P30CA014236, DUMC-PRO00006677
Study First Received:	April 28, 2009
Last Updated:	September 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
recurrent adult brain tumor

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2012