AzTrials
AzTrials

Glioblastoma MultiformePhase 3GBMNCT00045968

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

A Phase 3 study testing Dendritic cell immunotherapy in people with Glioblastoma Multiforme and Glioblastoma, run by Northwest Biotherapeutics at 86 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma Multiforme, Glioblastoma, GBM
What is being tested?
Dendritic cell immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
86 sitesin 4 countries
Study dates
Dec 2006to Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 12Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

86 sites in 4 countries.

86 sites in 4 countries

United States71 sites

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Sutter East Bay Neuroscience Institute-Eden Medical Center

    Castro Valley, California, 94546

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina Hospitals and Clinics

    Charleston, South Carolina, 29425

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • OhioHealth

    Columbus, Ohio, 43214

  • Baylor Research Institute

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • The Brain Tumor Center at JFK Medical Center

    Edison, New Jersey, 08818

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • University of Florida

    Gainesville, Florida, 32611

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

  • The Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • IU Simon Cancer Center

    Indianapolis, Indiana, 46202

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • UCSD Moores Cancer Center

    La Jolla, California, 93093

  • Long Island Brain Tumor Center at Neurological Surgery, P.C.

    Lake Success, New York, 11042

  • Markey Cancer Center/University of Kentucky

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Kaiser Permanente - Los Angeles

    Los Angeles, California, 90027

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Mount Sinai Community Clinical Oncology Program

    Miami Beach, Florida, 33140

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 23215

  • John Nasseff Neuroscience Institute at Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • New York University Clinical Cancer Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029-6574

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Oklahoma University Health Science Center

    Oklahoma City, Oklahoma, 73104

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Jefferson Hospital for Neuroscience

    Philadelphia, Pennsylvania, 19107

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Kaiser Permanente - Redwood City

    Redwood City, California, 94063

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • Cancer Therapy & Research at University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Swedish Hospital Neuroscience Research

    Seattle, Washington, 98122

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Overlook Hospital

    Summit, New Jersey, 07902

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Capital Health Regional Medical Center

    Trenton, New Jersey, 08638

  • Cadence Cancer Center

    Warrenville, Illinois, 60555

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Brain and Spine Surgeons of New York and Northern Westchester Hospital

    White Plains, New York, 10604

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany9 sites

  • Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie

    Bonn, North Rhine-Westphalia, 53105

  • Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

  • Universitätsklinikum Klinik für allgemeine Neurochirurgie

    Cologne, North Rhine-Westphalia, 50924

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie

    Frankfurt am Main, Hesse, 60528

  • BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie

    Halle, Saxony-Anhalt, 06112

  • Neurochirurgische Klinik

    Hamburg, 20246

  • Universitätsklinikum Heidelberg Neurochirurgische Klinik

    Heidelberg, Baden-Wurttemberg, 69120

  • Katharinenhospital

    Stuttgart, Baden-Wurttemberg, 70174

Other trials in Germany

United Kingdom4 sites

  • University Hospital of Birmingham NHS Foundation Trust

    Birmingham, West Midlands, N15 2WB

  • Addenbrookes NHS Trust

    Cambridge, Cambridgeshire, East Anglia, CB2 2QQ

  • Kings College Hosital NHS Foundation Trust

    London, Greater London, SE5 9RS

  • University College Hospital London

    London, Greater London, WC1E 6BT

Other trials in United Kingdom

Canada2 sites

  • Montreal Neurological Institute, McGill University

    Montreal, Quebec, H3A 2B4

  • CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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)

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)

Read the 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.

Being tested
Dendritic cell immunotherapy
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
Medical subject headings
Glioblastoma, Glioma, Brain Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic cell immunotherapyDrug

    Also called DCVax-L, DCVax, DCVax-Brain

    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.

Study groups in NCT00045968
Study groupRoleWhat they receive
treatment cohortActive comparatorNot described
Receives: Drug: Dendritic cell immunotherapy
Placebo ChohortPlacebo comparatorAutologous PBMC
Receives: Drug: Dendritic cell immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Until death

Secondary outcomes (1)

  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.

    Measured: Until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2002 (estimated)
  2. Study startDec 2006
  3. Primary completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045968
Sponsor's protocol ID
020221
Acronym
GBM
Status last verified
May 2022
First submitted
17 Sep 2002
Last updated
18 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Liau LM, Ashkan K, Brem S, Campian JL, Trusheim JE, Iwamoto FM, Tran DD, Ansstas G, Cobbs CS, Heth JA, Salacz ME, D'Andre S, Aiken RD, Moshel YA, Nam JY, Pillainayagam CP, Wagner SA, Walter KA, Chaudhary R, Goldlust SA, Lee IY, Bota DA, Elinzano H, Grewal J, Lillehei K, Mikkelsen T, Walbert T, Abram S, Brenner AJ, Ewend MG, Khagi S, Lovick DS, Portnow J, Kim L, Loudon WG, Martinez NL, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Giglio P, Gligich O, Krex D, Lindhorst SM, Lutzky J, Meisel HJ, Nadji-Ohl M, Sanchin L, Sloan A, Taylor LP, Wu JK, Dunbar EM, Etame AB, Kesari S, Mathieu D, Piccioni DE, Baskin DS, Lacroix M, May SA, New PZ, Pluard TJ, Toms SA, Tse V, Peak S, Villano JL, Battiste JD, Mulholland PJ, Pearlman ML, Petrecca K, Schulder M, Prins RM, Boynton AL, Bosch ML. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial. JAMA Oncol. 2023 Jan 1;9(1):112-121. doi: 10.1001/jamaoncol.2022.5370.

    PubMed 36394838

  • Liau LM, Ashkan K, Tran DD, Campian JL, Trusheim JE, Cobbs CS, Heth JA, Salacz M, Taylor S, D'Andre SD, Iwamoto FM, Dropcho EJ, Moshel YA, Walter KA, Pillainayagam CP, Aiken R, Chaudhary R, Goldlust SA, Bota DA, Duic P, Grewal J, Elinzano H, Toms SA, Lillehei KO, Mikkelsen T, Walbert T, Abram SR, Brenner AJ, Brem S, Ewend MG, Khagi S, Portnow J, Kim LJ, Loudon WG, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Lindhorst S, Lutzky J, Sloan AE, Schackert G, Krex D, Meisel HJ, Wu J, Davis RP, Duma C, Etame AB, Mathieu D, Kesari S, Piccioni D, Westphal M, Baskin DS, New PZ, Lacroix M, May SA, Pluard TJ, Tse V, Green RM, Villano JL, Pearlman M, Petrecca K, Schulder M, Taylor LP, Maida AE, Prins RM, Cloughesy TF, Mulholland P, Bosch ML. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018 May 29;16(1):142. doi: 10.1186/s12967-018-1507-6.

    PubMed 29843811

  • Badhiwala J, Decker WK, Berens ME, Bhardwaj RD. Clinical trials in cellular immunotherapy for brain/CNS tumors. Expert Rev Neurother. 2013 Apr;13(4):405-24. doi: 10.1586/ern.13.23.

    PubMed 23545055

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dendritic cell immunotherapy in people with Glioblastoma Multiforme and Glioblastoma, run by Northwest Biotherapeutics at 86 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Germany, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Until death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045968, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in