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Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: June 2, 2000
Last updated: October 26, 2011
Last verified: October 2011

RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.

Condition Intervention Phase
Brain and Central Nervous System Tumors Biological: bispecific antibody MDX447 Biological: lymphokine-activated killer cells Procedure: conventional surgery Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Study Start Date: March 1997
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
  • Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.

Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces

    • No astrocytoma, anaplastic astrocytoma, or oligodendroglioma
    • No infratentorial or multifocal tumor
  • Recurrence or progression following at least one prior therapy



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 2 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 g/dL


  • Bilirubin no greater than 2.0 mg/dL
  • ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine no greater than 2.0 times ULN


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other medical or psychiatric illness that would preclude study
  • No other concurrent malignancy except nonmelanoma skin cancer


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)

Endocrine therapy:

  • Concurrent steroid therapy allowed


  • At least 4 weeks since prior radiotherapy


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005813

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Principal Investigator: Camilo E Fadul, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00005813     History of Changes
Other Study ID Numbers: D9705
P30CA023108 ( U.S. NIH Grant/Contract )
NCI-G00-1783 ( Other Grant/Funding Number: NCI )
Study First Received: June 2, 2000
Last Updated: October 26, 2011

Keywords provided by Dartmouth-Hitchcock Medical Center:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017