Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
NCT ID: NCT00005813
Last Updated: 2011-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1997-03-31
2003-01-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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bispecific antibody MDX447
lymphokine-activated killer cells
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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Camilo E Fadul, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Other Identifiers
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NCI-G00-1783
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
D9705
Identifier Type: -
Identifier Source: org_study_id