title: Safety and feasibility of convection-enhanced delivery of Cotara for the treatment of malignant glioma: initial experience in 51 patients.
abstract: OBJECTIVE
  We report the safety and feasibility of using convection-enhanced delivery to administer Cotara (Peregrine Pharmaceuticals, Inc., Tustin, CA), a novel radioimmunotherapeutic agent, to patients with malignant glioma.
  
  
  METHODS
  Between April 1998 and November 2002, 51 patients with histologically confirmed malignant glioma received Cotara by convection-enhanced delivery. Most patients (88%) were treated with Cotara targeting tumor volume-dependent, single or multiple administrations of activity ranging from 0.5 to 3.0 mCi/cm3 of baseline clinical target volume. Two weeks after infusion, single-photon emission computed tomographic imaging determined the spatial distribution of Cotara. Patients were followed for as long as 41 months (average follow-up, 5 mo). Safety was evaluated on the basis of incidence of procedure-related, neurological, and systemic adverse events. Feasibility was evaluated in a subset of patients on the basis of the correlation between the prescribed activity and the actual activity administered to the targeted region.
  
  
  RESULTS
  Fifty-one patients, 37 with recurrent glioblastoma multiforme, 8 with newly diagnosed glioblastoma multiforme, and 6 with recurrent anaplastic astrocytomas, were treated. Average tumor volume was 36 +/- 27.6 cm3 (range, 5-168 cm3). Of the 67 infusions, 13 (19%), 52 (78%), and 2 (3%) delivered less than 90%, 100 +/- 10%, and more than 110%, respectively, of the prescribed administered activity to the targeted region. Treatment-emergent, drug-related central nervous system adverse events included brain edema (16%), hemiparesis (14%), and headache (14%). Systemic adverse events were mild. Several patients had objective responses to Cotara.
  
  
  CONCLUSIONS
  The majority of Cotara infusions delivered between 90 and 110% of the prescribed administered activity to the targeted region. This method of administration has an acceptable safety profile compared with literature reports of other therapeutics delivered by convection-enhanced delivery.
authors.affiliation: Department of Neurological Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Sunil J
authors.initials: SJ
authors.lastname: Patel
authors.forename: William R
authors.initials: WR
authors.lastname: Shapiro
authors.forename: Douglas W
authors.initials: DW
authors.lastname: Laske
authors.forename: Randy L
authors.initials: RL
authors.lastname: Jensen
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Asher
authors.forename: Barry W
authors.initials: BW
authors.lastname: Wessels
authors.forename: Susan P
authors.initials: SP
authors.lastname: Carpenter
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Shan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D001921:Brain / Q000000981:diagnostic imaging / Q000473:pathology; D001932:Brain Neoplasms / Q000145:classification / Q000175:diagnosis / Q000532:radiotherapy*; D003072:Cognition Disorders / Q000209:etiology; D004307:Dose-Response Relationship, Radiation; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005910:Glioma / Q000532:radiotherapy*; D006801:Humans; D017567:Karnofsky Performance Status / Q000706:statistics & numerical data; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D016499:Radioimmunotherapy / Q000009:adverse effects / Q000379:methods*; D019275:Radiopharmaceuticals / Q000008:administration & dosage*; D012189:Retrospective Studies; D013238:Stereotaxic Techniques; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D019275:Radiopharmaceuticals