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

Completed · Phase 1

Conditions studied: Glioblastoma Multiforme

In brief

This study will evaluate a type of immunotherapy in which the patient's immune system will be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be collected from blood and cultured to yield autologous DC. The DC will be mixed with purified peptides from the CD133 antigen. The DC vaccine will be given back to the patient over several months. The goal is to stimulate the patient's immune system to CD133 to kill the patient's glioblastoma tumor cells.

Key facts

Study ID

NCT02049489

Run by

Precision Life Sciences Group

People needed

20

Starts

2013-12-01

Expected to finish

2017-03-01

Last updated by the study team

2018-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any recurrence of a glioblastoma multiforme
• ≥ 18 years of age
• Human leukocyte antigen HLA A2 positive
• Karnofsky Performance Score (KPS) of ≥ 70%
• 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
• Female patients of child bearing potential must have negative serum pregnancy test
• If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
• Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
• Ability to understand and the willingness to sign a written informed consent document.
• Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment

You may not qualify if…

• Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
• 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
• New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
• 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)
• Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
• 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:
• Immunosuppressive disease
• Chronic renal disease / failure
• Concurrent neurodegenerative disease,
• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
• Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
• Known history of an autoimmune disorder
• Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
• Breastfeeding
• Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
• Contraindication to MRI
• Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• JFK New Jersey Neuroscience Institute — Edison, New Jersey, United States
• Penn State Hershey Neuroscience Institute — Hershey, Pennsylvania, United States
• Baylor Research Institute - Charles A. Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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