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A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Glioblastoma Multiforme, Glioblastoma, GBM, Grade IV Astrocytoma, Glioma, Brain Cancer, Brain Tumor

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Trial Information

A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)


This Phase III trial is designed to evaluate the impact on disease progression and 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 PFS (progression free survival), and the first secondary
endpoint is overall survival (OS). Other endpoints include performance status, immune
response, and also safety. Interim analyses to assess efficacy are incorporated in the trial
design.

Side effects reported from early trials are mostly mild, and may include skin reactions of
redness, pain & swelling at the injection site.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients.

Outcome Time Frame:

Time to tumor progression or death

Safety Issue:

No

Principal Investigator

Linda Liau, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Food and Drug Administration

Study ID:

020221

NCT ID:

NCT00045968

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma
  • GBM
  • Grade IV Astrocytoma
  • Glioma
  • Brain Cancer
  • Brain Tumor
  • 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
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Glioma

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
Rhode Island HospitalProvidence, Rhode Island  02903
Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Henry Ford HospitalDetroit, Michigan  48202
University Hospitals of ClevelandCleveland, Ohio  44106
Rush University Medical CenterChicago, Illinois  60612-3824
North Shore University HospitalManhasset, New York  11030
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Rochester Medical CenterRochester, New York  14642
Overlook HospitalSummit, New Jersey  07902-0220
Winthrop University HospitalMineola, New York  11501
University of Illinois Medical CenterChicago, Illinois  60612
City of HopeDuarte, California  91010
University of North CarolinaChapel Hill, North Carolina  27599
Georgetown University Medical CenterWashington, District of Columbia  20007
UCLALos Angeles, California  90095
UCI Medical CenterIrvine, California  92868
UCSD Moores Cancer CenterLa Jolla, California  93093
Sutter Institute for Medical ResearchSacramento, California  95816
South Pasadena Cancer CenterSouth Pasadena, California  91030
Mount Sinai CCOPMiami Beach, Florida  33140
Illinois Cancer CarePeoria, Illinois  61615
IU Simon Cancer CenterIndianapolis, Indiana  46202
Tufts Medical CenterBoston, Massachusetts  02111
University of Michigan, Department of NeurosurgeryAnn Arbor, Michigan  48109
St. Luke's HospitalKansas City, Missouri  64111
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Long Island Brain Tumor Centre at Neurological Surgery P.C.Commack, Great Neck, New York  11021
Huntington HospitalHuntington, New York  11743
New York University Clinical Cancer CenterNew York, New York  10016
South Nassau Community HospitalOceanside, New York  11572
Mercy Medical CenterRockville Centre, New York  11571-9024
Brain and Spine Surgeons of New York and Northern Westchester HospitalWhite Plains, New York  10604
UC Cancer InstituteCincinnati, Ohio  45267
Medical University of South Carolina Hospitals and ClinicsCharleston, South Carolina  29425
St. Thomas HospitalNashville, Tennessee  37205
Vanderbilt Ingram Cancer CenterNashville, Tennessee  37232
Baylor Research InstituteDallas, Texas  75246
Swedish Hospital Neuroscience ResearchSeattle, Washington  98122
Columbia University Medical CenterNew York, New York  10032
St. Joseph Hospital of OrangeOrange, California  92868
John Nasseff Neuroscience InstituteMinneapolis, Minnesota  55407
Yvonne Kew, MD, PhD, Neuro-Oncology ClinicHouston, Texas  77030
Cancer Therapy & Research at University of Texas Health Science Center San AntonioSan Antonio, Texas  78229