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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02049489
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Precision Life Sciences Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anthony Gringeri, Ph.D.
Principal Investigator Affiliation Precision Life Sciences Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of cancer cells and is associated with shortened survival. CD133 positive cancer stem cells are resistant to chemotherapy. Patients with recurrent glioblastoma who have the HLA A2 phenotype will receive autologous vaccine of DC pulsed with purified peptides from CD133. Approximately 20 patients with any recurrence of glioblastoma multiforme (GBM) will be treated. After informed consent and screening, patients will undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). Monocytes will be purified and cultured into dendritic cells (DC) that are pulsed with purified peptides from CD133 antigen. The pulsed dendritic cells will then be aliquoted and frozen. Patients will have the autologous DCs reinfused intradermally. Patients will receive at least four intradermal injections of the autologous DC vaccine and additional vaccines during a maintenance phase. The goal is to induce a cytotoxic T cell response to CD133 positive cells. The primary objective of the study is to assess safety and tolerability. Clinical response rates will be monitored as well as the immune responses to CD133.

Arms & Interventions

Arms

Experimental: ICT-121 DC vaccine

Autologous dendritic cells pulsed with peptide antigens

Interventions

Biological: - ICT-121 DC vaccine

autologous dendritic cells pulsed with peptide antigens

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

UC San Diego Moores Cancer Center, La Jolla, California

Status

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

JFK New Jersey Neuroscience Institute, Edison, New Jersey

Status

Address

JFK New Jersey Neuroscience Institute

Edison, New Jersey, 08820

Hershey, Pennsylvania

Status

Address

Penn State Hershey Neuroscience Institute

Hershey, Pennsylvania, 17033

Dallas, Texas

Status

Address

Baylor Research Institute - Charles A. Sammons Cancer Center

Dallas, Texas, 75246