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In this study the patient's own tumor cells, removed during a surgical craniotomy, are treated with an investigational antisense molecule (IGF-1R/AS ODN) designed to shut down a target surface receptor, then re-implanted inside small diffusion chambers in the patient's abdomen within 24 hours of surgery. The approach is intended to trigger tumor cell death (apoptosis) and activate the immune system against the tumor. This Phase 1 trial enrolled patients whose glioblastoma multiforme recurred after standard initial treatment and was suitable for repeat resection.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Failure after previous standard of care initial treatment of glioblastoma multiforme. * Documentation by MRI of an interval increase in nodular gadolinium enhancement consistent with recurrent malignant glioma suitable for therapeutic re-resection. * Previous pathological diagnosis of WHO Grade IV glioma. * All previous treatment interventions are acceptable. * Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 or a KPS (Karnofsky Performance Score) of at least 60. * Patients must be 18 years of age or older. * Patients must sign an approved informed consent. * Hemodynamically stable, consistent with Standard of Care values for patients undergoing elective tumor resection. Exclusion Criteria: * Females who are pregnant, nursing, or not inclined to use adequate contraceptive methods if necessary to prevent pregnancy during the study. * An active second primary malignancy with the exception of basal cell or squamous cell skin carcinoma. * Major concomitant medical illness inclusive of severe chronic obstructive pulmonary disease, symptomatic coronary artery disease, heart failure, recent major cerebrovascular accident, brittle diabetes, renal dialysis, end stage liver disease, or labile hypertension. * Patients who have a history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products. * Patients with an abnormal INR (International Normalized Ratio of greater than 1.3), if repeatable and refractory to correction by routine methods. * Patients who have documented deep venous thrombosis