A Study of ICT-121 Dendritic Cell Vaccine in Recurrent Glioblastoma

Exclusion Criteria

• •1. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
• •2. Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
• •3. New York Heart Association \>/= Grade 3 congestive heart failure within 6 months prior to study entry
• •4. Uncontrolled or significant cardiovascular disease, including:
• •* Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
• •* Uncontrolled angina within 6 months
• •* Diagnosed or suspected congenital long QT syndrome
• •* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
• •* Clinically significant abnormality on electrocardiogram (ECG)
• •5. Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
• •6. Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following:
• •1. Immunosuppressive disease
• •2. Chronic renal disease / failure
• •3. Concurrent neurodegenerative disease,
• •4. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
• •7. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
• •8. Known history of an autoimmune disorder
• •9. Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
• •10. Breastfeeding
• •12. Contraindication to MRI
• •13. Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -