Clinical Trial Details
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NCT01550523 : Pilot Immunotherapy Trial for Recurrent Malignant Gliomas
PhasePhase 1
AgesMin: 18 Years Max: N/A
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
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