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

Trial Title: Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer

NCT ID: NCT00045968

Condition: Glioblastoma Multiforme
Glioblastoma
GBM
Grade IV Astrocytoma
Glioma
Brain Cancer
Brain Tumor

Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Immunomodulating Agents

Conditions: Keywords:
oncology
neurology
glioma
brain tumor
brain cancer
glioblastoma multiforme
glioblastoma
newly diagnosed glioblastoma
immunotherapy
dendritic cells
immune therapy
GBM
Brain cancer, primary
tumor vaccine
grade IV astrocytoma
DCVax
Grade IV brain cancer

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Dendritic cell immunotherapy
Description: Two intradermal (i.d.) injections of DCVax-L(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.
Arm group label: Placebo Chohort
Arm group label: treatment cohort

Other name: DCVax-L

Other name: DCVax

Other name: DCVax-Brain

Summary: The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Detailed description: This Phase III trial is designed to evaluate the impact on survival time, as well as safety, in patients following treatment with DCVax(R)-L, 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. Eligible patients will receive a series of injections of DCVax-L, to activate and then boost the immune response to the tumor cells. The primary study endpoint is OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma. Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain & swelling at the injection site.

Criteria for eligibility:
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. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations 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 ≤70 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 not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately. - 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-L. DCVax-L 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35294
Country: United States

Facility:
Name: University of Arkansas for Medical Sciences

Address:
City: Little Rock
Zip: 72205
Country: United States

Facility:
Name: Sutter East Bay Neuroscience Institute-Eden Medical Center

Address:
City: Castro Valley
Zip: 94546
Country: United States

Facility:
Name: City of Hope

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: UCSD Moores Cancer Center

Address:
City: La Jolla
Zip: 93093
Country: United States

Facility:
Name: Kaiser Permanente - Los Angeles

Address:
City: Los Angeles
Zip: 90027
Country: United States

Facility:
Name: UCLA Medical Center

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: Hoag Memorial Hospital Presbyterian

Address:
City: Newport Beach
Zip: 92663
Country: United States

Facility:
Name: St. Joseph Hospital of Orange

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: University of California, Irvine Medical Center

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Kaiser Permanente - Redwood City

Address:
City: Redwood City
Zip: 94063
Country: United States

Facility:
Name: Sutter Institute for Medical Research

Address:
City: Sacramento
Zip: 95816
Country: United States

Facility:
Name: University of Colorado Cancer Center

Address:
City: Aurora
Zip: 80045
Country: United States

Facility:
Name: Colorado Neurological Institute

Address:
City: Englewood
Zip: 80113
Country: United States

Facility:
Name: Georgetown University Medical Center

Address:
City: Washington
Zip: 20057
Country: United States

Facility:
Name: University of Florida

Address:
City: Gainesville
Zip: 32611
Country: United States

Facility:
Name: Memorial Cancer Institute

Address:
City: Hollywood
Zip: 33021
Country: United States

Facility:
Name: Mount Sinai Community Clinical Oncology Program

Address:
City: Miami Beach
Zip: 33140
Country: United States

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: Piedmont Atlanta Hospital

Address:
City: Atlanta
Zip: 30309
Country: United States

Facility:
Name: Rush University Medical Center

Address:
City: Chicago
Zip: 60612
Country: United States

Facility:
Name: Illinois Cancer Care

Address:
City: Peoria
Zip: 61615
Country: United States

Facility:
Name: Cadence Cancer Center

Address:
City: Warrenville
Zip: 60555
Country: United States

Facility:
Name: IU Simon Cancer Center

Address:
City: Indianapolis
Zip: 46202
Country: United States

Facility:
Name: University of Kansas Cancer Center

Address:
City: Westwood
Zip: 66205
Country: United States

Facility:
Name: Markey Cancer Center/University of Kentucky

Address:
City: Lexington
Zip: 40536
Country: United States

Facility:
Name: Norton Cancer Institute

Address:
City: Louisville
Zip: 40202
Country: United States

Facility:
Name: Tufts Medical Center

Address:
City: Boston
Zip: 02111
Country: United States

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: University of Michigan Cancer Center

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Spectrum Health

Address:
City: Grand Rapids
Zip: 49503
Country: United States

Facility:
Name: John Nasseff Neuroscience Institute at Abbott Northwestern Hospital

Address:
City: Minneapolis
Zip: 55407
Country: United States

Facility:
Name: St. Luke's Hospital

Address:
City: Kansas City
Zip: 64111
Country: United States

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: The Brain Tumor Center at JFK Medical Center

Address:
City: Edison
Zip: 08818
Country: United States

Facility:
Name: John Theurer Cancer Center at Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: The Valley Hospital

Address:
City: Ridgewood
Zip: 07450
Country: United States

Facility:
Name: Overlook Hospital

Address:
City: Summit
Zip: 07902
Country: United States

Facility:
Name: Capital Health Regional Medical Center

Address:
City: Trenton
Zip: 08638
Country: United States

Facility:
Name: Long Island Brain Tumor Center at Neurological Surgery, P.C.

Address:
City: Lake Success
Zip: 11042
Country: United States

Facility:
Name: North Shore University Hospital

Address:
City: Manhasset
Zip: 11030
Country: United States

Facility:
Name: New York University Clinical Cancer Center

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: Mount Sinai Medical Center

Address:
City: New York
Zip: 10029-6574
Country: United States

Facility:
Name: Columbia University Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Facility:
Name: University of Rochester Medical Center

Address:
City: Rochester
Zip: 14642
Country: United States

Facility:
Name: Stony Brook Medicine

Address:
City: Stony Brook
Zip: 11794
Country: United States

Facility:
Name: Brain and Spine Surgeons of New York and Northern Westchester Hospital

Address:
City: White Plains
Zip: 10604
Country: United States

Facility:
Name: University of North Carolina, Chapel Hill

Address:
City: Chapel Hill
Zip: 27514
Country: United States

Facility:
Name: Wake Forest Baptist Medical Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Facility:
Name: University of Cincinnati Cancer Institute

Address:
City: Cincinnati
Zip: 45267
Country: United States

Facility:
Name: University Hospitals Seidman Cancer Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Cleveland Clinic Foundation

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Ohio State University

Address:
City: Columbus
Zip: 43210
Country: United States

Facility:
Name: OhioHealth

Address:
City: Columbus
Zip: 43214
Country: United States

Facility:
Name: Oklahoma University Health Science Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Facility:
Name: Geisinger Medical Center

Address:
City: Danville
Zip: 17822
Country: United States

Facility:
Name: Hospital of the University of Pennsylvania

Address:
City: Philadelphia
Zip: 19104
Country: United States

Facility:
Name: Jefferson Hospital for Neuroscience

Address:
City: Philadelphia
Zip: 19107
Country: United States

Facility:
Name: Temple University School of Medicine

Address:
City: Philadelphia
Zip: 19140
Country: United States

Facility:
Name: Rhode Island Hospital

Address:
City: Providence
Zip: 02903
Country: United States

Facility:
Name: Medical University of South Carolina Hospitals and Clinics

Address:
City: Charleston
Zip: 29425
Country: United States

Facility:
Name: Saint Thomas Research Institute

Address:
City: Nashville
Zip: 37205
Country: United States

Facility:
Name: Vanderbilt Ingram Cancer Center

Address:
City: Nashville
Zip: 37232
Country: United States

Facility:
Name: Baylor Research Institute

Address:
City: Dallas
Zip: 75246
Country: United States

Facility:
Name: The Methodist Hospital

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: University of Texas Health Science Center at Houston

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Cancer Therapy & Research at University of Texas Health Science Center San Antonio

Address:
City: San Antonio
Zip: 78229
Country: United States

Facility:
Name: Benaroya Research Institute at Virginia Mason

Address:
City: Seattle
Zip: 98101
Country: United States

Facility:
Name: Swedish Hospital Neuroscience Research

Address:
City: Seattle
Zip: 98122
Country: United States

Facility:
Name: Aurora Saint Luke's Medical Center

Address:
City: Milwaukee
Zip: 23215
Country: United States

Facility:
Name: Montreal Neurological Institute, McGill University

Address:
City: Montreal
Zip: H3A 2B4
Country: Canada

Facility:
Name: CHUS - Hôpital Fleurimont

Address:
City: Sherbrooke
Zip: J1H 5N4
Country: Canada

Facility:
Name: Universitätsklinikum Heidelberg Neurochirurgische Klinik

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Facility:
Name: Katharinenhospital

Address:
City: Stuttgart
Zip: 70174
Country: Germany

Facility:
Name: Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie

Address:
City: Frankfurt
Zip: 60528
Country: Germany

Facility:
Name: Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie

Address:
City: Bonn
Zip: 53105
Country: Germany

Facility:
Name: Universitätsklinikum Klinik für allgemeine Neurochirurgie

Address:
City: Köln
Zip: 50924
Country: Germany

Facility:
Name: BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie

Address:
City: Halle
Zip: 06112
Country: Germany

Facility:
Name: Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH

Address:
City: Chemnitz
Zip: 09116
Country: Germany

Facility:
Name: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Address:
City: Dresden
Zip: 01307
Country: Germany

Facility:
Name: Neurochirurgische Klinik

Address:
City: Hamburg
Zip: 20246
Country: Germany

Facility:
Name: Addenbrookes NHS Trust

Address:
City: Cambridge
Zip: CB2 2QQ
Country: United Kingdom

Facility:
Name: Kings College Hosital NHS Foundation Trust

Address:
City: London
Zip: SE5 9RS
Country: United Kingdom

Facility:
Name: University College Hospital London

Address:
City: London
Zip: WC1E 6BT
Country: United Kingdom

Facility:
Name: University Hospital of Birmingham NHS Foundation Trust

Address:
City: Birmingham
Zip: N15 2WB
Country: United Kingdom

Start date: December 2006

Lead sponsor:
Agency: Northwest Biotherapeutics
Agency class: Industry

Source: Northwest Biotherapeutics

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00045968
http://www.nwbio.com