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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005813 |
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 |
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Brain and Central Nervous System Tumors |
Biological: bispecific antibody MDX447 Biological: lymphokine-activated killer cells Procedure: conventional surgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme |
Study Start Date: | March 1997 |
OBJECTIVES:
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756-0002 |
Study Chair: | Camilo E. Fadul, MD | Norris Cotton Cancer Center |
Study ID Numbers: | CDR0000067815, DMS-9705, NCI-G00-1783 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005813 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Immunologic Factors Astrocytoma Central Nervous System Neoplasms Recurrence Antibodies, Bispecific Neuroectodermal Tumors Antibodies |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Nervous System Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Immunologic Factors Astrocytoma Physiological Effects of Drugs Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Pharmacologic Actions Antibodies, Bispecific |
Neuroectodermal Tumors Antibodies Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |