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

Sponsor
Northwest Biotherapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00045968
Collaborator
(none)
348
Enrollment
86
Locations
2
Arms
4
Patients Per Site

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Dendritic cell immunotherapy
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
348 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
Study Start Date :
Dec 1, 2006
Anticipated Primary Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: treatment cohort

Drug: Dendritic cell immunotherapy
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.
Other Names:
  • DCVax-L
  • DCVax
  • DCVax-Brain

    		•
    Placebo Comparator: Placebo Chohort

    Autologous PBMC

    Drug: Dendritic cell immunotherapy
    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.
    Other Names:
  • DCVax-L
  • DCVax
  • DCVax-Brain

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma. [Until death]

    Secondary Outcome Measures

    1. The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM. [Until death]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 Sutter East Bay Neuroscience Institute-Eden Medical Center Castro Valley California United States 94546
    4 City of Hope Duarte California United States 91010
    5 UCSD Moores Cancer Center La Jolla California United States 93093
    6 Kaiser Permanente - Los Angeles Los Angeles California United States 90027
    7 UCLA Medical Center Los Angeles California United States 90095
    8 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92663
    9 St. Joseph Hospital of Orange Orange California United States 92868
    10 University of California, Irvine Medical Center Orange California United States 92868
    11 Kaiser Permanente - Redwood City Redwood City California United States 94063
    12 Sutter Institute for Medical Research Sacramento California United States 95816
    13 University of Colorado Cancer Center Aurora Colorado United States 80045
    14 Colorado Neurological Institute Englewood Colorado United States 80113
    15 Georgetown University Medical Center Washington District of Columbia United States 20057
    16 University of Florida Gainesville Florida United States 32611
    17 Memorial Cancer Institute Hollywood Florida United States 33021
    18 Mount Sinai Community Clinical Oncology Program Miami Beach Florida United States 33140
    19 Moffitt Cancer Center Tampa Florida United States 33612
    20 Piedmont Atlanta Hospital Atlanta Georgia United States 30309
    21 Rush University Medical Center Chicago Illinois United States 60612
    22 Illinois Cancer Care Peoria Illinois United States 61615
    23 Cadence Cancer Center Warrenville Illinois United States 60555
    24 IU Simon Cancer Center Indianapolis Indiana United States 46202
    25 University of Kansas Cancer Center Westwood Kansas United States 66205
    26 Markey Cancer Center/University of Kentucky Lexington Kentucky United States 40536
    27 Norton Cancer Institute Louisville Kentucky United States 40202
    28 Tufts Medical Center Boston Massachusetts United States 02111
    29 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    30 University of Michigan Cancer Center Ann Arbor Michigan United States 48109
    31 Henry Ford Hospital Detroit Michigan United States 48202
    32 Spectrum Health Grand Rapids Michigan United States 49503
    33 John Nasseff Neuroscience Institute at Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
    34 St. Luke's Hospital Kansas City Missouri United States 64111
    35 Washington University School of Medicine Saint Louis Missouri United States 63110
    36 The Brain Tumor Center at JFK Medical Center Edison New Jersey United States 08818
    37 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    38 The Valley Hospital Ridgewood New Jersey United States 07450
    39 Overlook Hospital Summit New Jersey United States 07902
    40 Capital Health Regional Medical Center Trenton New Jersey United States 08638
    41 Long Island Brain Tumor Center at Neurological Surgery, P.C. Lake Success New York United States 11042
    42 North Shore University Hospital Manhasset New York United States 11030
    43 New York University Clinical Cancer Center New York New York United States 10016
    44 Mount Sinai Medical Center New York New York United States 10029-6574
    45 Columbia University Medical Center New York New York United States 10032
    46 University of Rochester Medical Center Rochester New York United States 14642
    47 Stony Brook Medicine Stony Brook New York United States 11794
    48 Brain and Spine Surgeons of New York and Northern Westchester Hospital White Plains New York United States 10604
    49 University of North Carolina, Chapel Hill Chapel Hill North Carolina United States 27514
    50 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157
    51 University of Cincinnati Cancer Institute Cincinnati Ohio United States 45267
    52 University Hospitals Seidman Cancer Center Cleveland Ohio United States 44106
    53 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    54 Ohio State University Columbus Ohio United States 43210
    55 OhioHealth Columbus Ohio United States 43214
    56 Oklahoma University Health Science Center Oklahoma City Oklahoma United States 73104
    57 Geisinger Medical Center Danville Pennsylvania United States 17822
    58 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    59 Jefferson Hospital for Neuroscience Philadelphia Pennsylvania United States 19107
    60 Temple University School of Medicine Philadelphia Pennsylvania United States 19140
    61 Rhode Island Hospital Providence Rhode Island United States 02903
    62 Medical University of South Carolina Hospitals and Clinics Charleston South Carolina United States 29425
    63 Saint Thomas Research Institute Nashville Tennessee United States 37205
    64 Vanderbilt Ingram Cancer Center Nashville Tennessee United States 37232
    65 Baylor Research Institute Dallas Texas United States 75246
    66 The Methodist Hospital Houston Texas United States 77030
    67 University of Texas Health Science Center at Houston Houston Texas United States 77030
    68 Cancer Therapy & Research at University of Texas Health Science Center San Antonio San Antonio Texas United States 78229
    69 Benaroya Research Institute at Virginia Mason Seattle Washington United States 98101
    70 Swedish Hospital Neuroscience Research Seattle Washington United States 98122
    71 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 23215
    72 Montreal Neurological Institute, McGill University Montreal Quebec Canada H3A 2B4
    73 CHUS - Hôpital Fleurimont Sherbrooke Quebec Canada J1H 5N4
    74 Universitätsklinikum Heidelberg Neurochirurgische Klinik Heidelberg Baden-Württemberg Germany 69120
    75 Katharinenhospital Stuttgart Baden-Württemberg Germany 70174
    76 Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie Frankfurt Hesse Germany 60528
    77 Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie Bonn North Rhine-Westphalia Germany 53105
    78 Universitätsklinikum Klinik für allgemeine Neurochirurgie Köln North Rhine-Westphalia Germany 50924
    79 BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie Halle Saxony-Anhalt Germany 06112
    80 Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH Chemnitz Saxony Germany 09116
    81 Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden Saxony Germany 01307
    82 Neurochirurgische Klinik Hamburg Germany 20246
    83 Addenbrookes NHS Trust Cambridge Cambridgeshire, East Anglia United Kingdom CB2 2QQ
    84 Kings College Hosital NHS Foundation Trust London Greater London United Kingdom SE5 9RS
    85 University College Hospital London London Greater London United Kingdom WC1E 6BT
    86 University Hospital of Birmingham NHS Foundation Trust Birmingham West Midlands United Kingdom N15 2WB

    Sponsors and Collaborators

    • Northwest Biotherapeutics

    Investigators

    • Principal Investigator: Linda Liau, M.D., University of California, Los Angeles
    • Study Director: Marnix L. Bosch, MBA, PhD, Northwest Biotherapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Northwest Biotherapeutics
    ClinicalTrials.gov Identifier:
    NCT00045968
    Other Study ID Numbers:
    • 020221
    First Posted:
    Sep 19, 2002
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Northwest Biotherapeutics
    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
    Additional relevant MeSH terms:
    Glioblastoma
    Glioma
    Brain Neoplasms
    Astrocytoma

    Study Results

    No Results Posted as of May 18, 2022