Expired Study
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Lebanon, New Hampshire 03756


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00005813


Primary Contact:

Principal Investigator
Camilo E Fadul, MD
Dartmouth-Hitchcock Medical Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03756
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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