Study of a Drug [DCVax®-Brain] to Treat Newly Diagnosed GBM Brain Cancer - Full Text View

Sponsor:	Northwest Biotherapeutics
Information provided by:	Northwest Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00045968

Purpose

The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-Brain in patients with newly diagnosed GBM for whom surgery is indicated. Patient must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-Brain.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: Dendritic cell immunotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Northwest Biotherapeutics:

Primary Outcome Measures:

The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-Brain and control patients. [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to compare overall survival and time to disease progression between DCVax-Brain treated and control patients. [ Time Frame: Until Death ] [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
treatment cohort: Active Comparator	Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-Brain (treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.
Placebo Chohort: Placebo Comparator Autologous PBMC	Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-Brain (treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.

Detailed Description:

This Phase II trial is designed to evaluate the safety, clinical response and survival of patients following treatment with DCVax(R)-Brain, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to "teach" the immune system how to recognize brain cancer cells. Side effects reported from the Phase I trial include skin reactions of redness, pain & swelling at the injection site, nausea/vomiting, headache & fatigue, diarrhea & low-grade fever.

Full details on this Phase II clinical trial are available in the informed consent.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must meet the following inclusion criteria. All tests and eligibility criteria must be completed within four weeks of completion of radiation and chemotherapy, following surgery.

Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee.
Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process.
Subjects ≥18 and <66 years of age at surgery who are capable of informed consent. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
Patients must have a life expectancy of >8 weeks.
Patients must have a KPS rating of ≥70 at the baseline visit (Visit 3).
Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization.
Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis.
Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-Brain. DCVax-Brain treatment must be given as described and temozolomide/Temodar treatment schedules must be given essentially according to the Stupp Protocol.
Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white blood count 3600-11,000mm3, absolute granulocyte count ≥1,500/mm3, absolute lymphocyte count ≥1,000/mm3, and platelet count ≥100K/mm3. Eligibility level of hemoglobin can be reached by transfusion.
Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤1.5 times upper limits of normals (ULN) and total bilirubin ≤1.5mg/dl), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045968

Locations

United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
University of Cincinnati, Hematology/Oncology Division
Cincinnati, Ohio, United States, 45267
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Northwest Biotherapeutics

Investigators

Principal Investigator:	Tom Mikkelsen, M.D.	Henry Ford Hospital
Principal Investigator:	Linda Liau, MD, PhD	University of California, Los Angeles
Principal Investigator:	Michael L Gruber, MD	Atlantic Health System
Principal Investigator:	Michael L Gruber, MD	New York University Clinical Cancer Center
Principal Investigator:	Margie Gerena-Lewis, M.D.	University of Cincinnati
Principal Investigator:	John Villano, M.D.	University of Illinois
Principal Investigator:	John Trusheim, M.D.	Virginia Piper Cancer Institute
Principal Investigator:	Jason Heth, M.D.	University of Michigan
Principal Investigator:	Andrew E. Sloan, M.D.	University Hospitals of Cleveland
Principal Investigator:	Karen Fink, M.D., PhD	Baylor Research Institute
Principal Investigator:	Steven Brem, MD	H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator:	Kevin Walter, MD	University of Rochester

More Information

Additional Information:

Northwest Biotherapeutics, Inc. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Northwest Biotherapeutics, Inc. ( Marnix L. Bosch, MBA, PhD, Chief Technical Officer )
Study ID Numbers:	020221
Study First Received:	September 17, 2002
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00045968 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Northwest Biotherapeutics:

oncology
neurology
glioblastoma multiforme
newly diagnosed glioblastoma multiforme

Additional relevant MeSH terms:

Neuroectodermal Tumors
Glioblastoma
Neoplasms
Neoplasms by Histologic Type
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 11, 2009