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

May 12, 2022 updated by: Northwest Biotherapeutics

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute, McGill University
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS - Hôpital Fleurimont
  • Germany
      • Hamburg, Germany, 20246
        • Neurochirurgische Klinik
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg Neurochirurgische Klinik
      • Stuttgart, Baden-Württemberg, Germany, 70174
        • Katharinenhospital
    • Hesse
      • Frankfurt, Hesse, Germany, 60528
        • Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53105
        • Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
      • Köln, North Rhine-Westphalia, Germany, 50924
        • Universitätsklinikum Klinik für allgemeine Neurochirurgie
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
      • Dresden, Saxony, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06112
        • BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
  • United Kingdom
    • Cambridgeshire, East Anglia
      • Cambridge, Cambridgeshire, East Anglia, United Kingdom, CB2 2QQ
        • Addenbrookes NHS Trust
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Kings College Hosital NHS Foundation Trust
      • London, Greater London, United Kingdom, WC1E 6BT
        • University College Hospital London
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, N15 2WB
        • University Hospital of Birmingham NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Castro Valley, California, United States, 94546
        • Sutter East Bay Neuroscience Institute-Eden Medical Center
      • Duarte, California, United States, 91010
        • City of Hope
      • La Jolla, California, United States, 93093
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente - Los Angeles
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • Orange, California, United States, 92868
        • St. Joseph Hospital of Orange
      • Redwood City, California, United States, 94063
        • Kaiser Permanente - Redwood City
      • Sacramento, California, United States, 95816
        • Sutter Institute for Medical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Community Clinical Oncology Program
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
      • Warrenville, Illinois, United States, 60555
        • Cadence Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Iu Simon Cancer Center
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center/University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • The Brain Tumor Center at JFK Medical Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
      • Trenton, New Jersey, United States, 08638
        • Capital Health Regional Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Long Island Brain Tumor Center at Neurological Surgery, P.C.
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029-6574
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • New York University Clinical Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
      • White Plains, New York, United States, 10604
        • Brain and Spine Surgeons of New York and Northern Westchester Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina, Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Cancer Institute
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43214
        • OhioHealth
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Science Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University School of Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Hospital for Neuroscience
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hospitals and Clinics
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Ingram Cancer Center
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy & Research at University of Texas Health Science Center San Antonio
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason
      • Seattle, Washington, United States, 98122
        • Swedish Hospital Neuroscience Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 23215
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Until death

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Until death
Until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwest Biotherapeutics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 17, 2002

First Submitted That Met QC Criteria

September 18, 2002

First Posted (Estimate)

September 19, 2002

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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