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

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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 cells Procedure: adjuvant therapy Procedure: therapeutic conventional surgery	Phase I

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility and safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Humoral and cellular immune responses [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2009
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890032

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 Comprehensive Cancer Center ( Duane Mitchell )
Study ID Numbers:	CDR0000630701, DUMC-PRO00006677
Study First Received:	April 28, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00890032 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Adjuvants, Immunologic
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Glioblastoma Multiforme
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009