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

NCT02049489 | Completed Phase 1 DMC

• 1 other identifier: ICT-121 DC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

ICT-121; glioblastoma; immunotherapy; dendritic cell vaccine; CD133

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of an autologous ICT-121 DC vaccine

  To assess safety of the autologous ICT-121 DC vaccine the following will be monitored: Serious Adverse events, treatment emergent adverse events, treatment related toxicities

  2-3 years

Secondary Outcomes (1)

• Response rate and immune response to autologous ICT-121 DC vaccine

  2-3 years

Study Arms (1)

ICT-121 DC vaccine

EXPERIMENTAL

Autologous dendritic cells pulsed with peptide antigens

Biological: ICT-121 DC vaccine

Interventions

ICT-121 DC vaccine BIOLOGICAL

autologous dendritic cells pulsed with peptide antigens

ICT-121 DC vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Precision Life Sciences Group: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

JFK New Jersey Neuroscience Institute

Edison, New Jersey, 08820, United States

Location

Penn State Hershey Neuroscience Institute

Hershey, Pennsylvania, 17033, United States

Location

Baylor Research Institute - Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Anthony Gringeri, Ph.D.

  Precision Life Sciences Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

US (6)