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

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring ICT-121, glioblastoma, immunotherapy, dendritic cell vaccine, CD133 Read More

Inclusion Criteria:

1. Any recurrence of a glioblastoma multiforme
2. ≥ 18 years of age
3. Human leukocyte antigen HLA A2 positive
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 < 2 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 prior to first treatment

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
11. Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
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 -