Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT00005813 |
Recruitment Status
:
Completed
First Posted
: May 20, 2003
Last Update Posted
: October 27, 2011
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Biological: bispecific antibody MDX447 Biological: lymphokine-activated killer cells Procedure: conventional surgery | Phase 1 |
OBJECTIVES:
- 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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | 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 |
Actual Primary Completion Date : | January 2003 |
Actual Study Completion Date : | January 2003 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 2 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2.0 times ULN
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
Endocrine therapy:
- Concurrent steroid therapy allowed
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005813
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 |
Principal Investigator: | Camilo E Fadul, MD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00005813 History of Changes |
Other Study ID Numbers: |
D9705 P30CA023108 ( U.S. NIH Grant/Contract ) NCI-G00-1783 ( Other Grant/Funding Number: NCI ) |
First Posted: | May 20, 2003 Key Record Dates |
Last Update Posted: | October 27, 2011 |
Last Verified: | October 2011 |
Keywords provided by Dartmouth-Hitchcock Medical Center:
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Antibodies Immunoglobulins Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs |