Clinical Trial Details
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NCT02507583 : Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Documentation by MR of a gadolinium-enhancing intraparenchymal mass consistent with
malignant glioma.

- Frozen section diagnosis of WHO Grade IV glioma, confirmed with permanent section and
immunopositive for IGF-1R.

- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or a
Karnofsky Performance Score (KPS) of at least 60.

- Must be 18 years of age or older.

- 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, multiple sclerosis, symptomatic coronary artery disease, heart failure,
recent major cerebrovascular accident, brittle diabetes, renal dialysis, end stage
liver disease, labile hypertension, or any autoimmune disorder.

- A history of heparin-induced thrombocytopenia or hypersensitivity to heparin,
enoxaparin, or pork products.

- An abnormal International Normalized Ratio (INR) of greater than 1.3, if repeatable
and refractory to correction by routine methods.

- Documented deep venous thrombosis
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