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

Dartmouth-Hitchcock Medical Center

Overview

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.

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

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

bispecific antibody MDX447BIOLOGICAL

lymphokine-activated killer cellsBIOLOGICAL

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Data from ClinicalTrials.gov

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