Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma

Exclusion Criteria

• •2. Complete resection of tumor: gross total resection consisting of no gadolinium enhancement or linear gadolinium enhancement along the resection cavity; or subtotal resection consisting of linear enhancement with nodular gadolinium enhancement of less than 1cm x 1cm x 1cm total volume. The qualifying surgical resection must have been performed at Cedars-Sinai in order to allow for tumor stem cell antigen testing.
• •3. ≥ 18 years of age
• •4. Karnofsky Performance Score (KPS) of ≥ 70%
• •5. Baseline hematologic studies and chemistry profiles must meet the following criteria: hemoglobin (Hgb) \> 9.9 g/dL, absolute neutrophil count (ANC) \> 1000/mm3, platelet count \> 100,000/mm3, blood urea nitrogen (BUN) \< 30 mg/dL, creatinine \< 1.4 mg/dL, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 4x upper limit of normal (ULN), prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
• •6. Female patients of child bearing potential must have negative serum pregnancy test
• •7. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
• •8. Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
• •9. Ability to understand and the willingness to sign a written informed consent document.
• •10. Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks to Grade 1 or less
• •1. Presence of any other active malignancy or prior history of malignancy that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results.
• •2. Clinically significant pulmonary, cardiac or other systemic disease that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results - for example:
• •1. New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry;
• •2. Uncontrolled or significant cardiovascular disease, including:
• •* Myocardial infarction 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)
• •3. Pulmonary disease including or greater than grade 2 dyspnea, laryngeal edema, grade 3 pulmonary edema, pulmonary hypertension according to CTCAE 4.03
• •4. 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: (a) Immunosuppressive disease, (b) Chronic renal disease / failure, (c) Concurrent neurodegenerative disease, (d) Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
• •5. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
• •6. Active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• •7. Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
• •8. Breastfeeding
• •9. Received any other therapeutic investigational agent within 30 days of enrollment
• •10. Contraindication to MRI
• •11. Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis.
• •12. Any foreseeable scheduling constraint that would prevent a patient in Cohort A from starting chemoradiation within 7 weeks of surgery, and any foreseeable scheduling constraint that would prevent a patient in Cohort B from starting the Vaccine Induction Phase within 7 weeks of surgery.
• •13. Any concomitant chemotherapy other than standard-dose temozolomide for patients in Cohort A; any concomitant chemotherapy for patients in Cohort B, with the exception of the antiangiogenic humanized monoclonal antibody bevacizumab, which is allowed for patients treated with bevacizumab prior to enrollment in the trial.