A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

ImmunoCellular Therapeutics, Ltd.

ClinicalTrials.gov Identifier:

NCT01280552

First received: January 19, 2011

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 19, 2011
Last Updated Date	October 17, 2012
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 11, 2012)	Overall survival (OS) [ Time Frame: 2 -3 years ] [ Designated as safety issue: No ] The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed)
Original Primary Outcome Measures ^ICMJE (submitted: January 19, 2011)	Overall survival (OS) and progression-free survival (PFS) [ Time Frame: 2 -3 years ] [ Designated as safety issue: No ] Composite endpoint. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) PFS defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed
Change History	Complete list of historical versions of study NCT01280552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 11, 2012)	PFS, immune response, safety [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ] Secondary Endpoints To compare progression-free survival (PFS) in patients when treated with ICT 107 versus Control To determine the safety and tolerability of ICT 107 To describe the immune response in patients treated with ICT 107 To determine predictors of response
Original Secondary Outcome Measures ^ICMJE (submitted: January 19, 2011)	Rate of OS, PFS, immune response, safety [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ] Secondary Endpoints The rates of OS and PFS at 6 months after surgery, then assessed every 3 months until the end of the study Immune response of ICT-107 Number of Grade 3 or 4 toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAEs) Number of serious adverse events (SAEs) Number of treatment emergent adverse events (TEAEs) Treatment related toxicities Predictors of response
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Official Title ^ICMJE	A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation
Brief Summary	This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Detailed Description	The proposed phase 2 study is a randomized, double blind, controlled study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemoradiation. The phase 1 clinical trial demonstrated safety and promising efficacy in a small, open-label study. The purpose of this study is to provide information from a larger, controlled clinical trial. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Patients will have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment into the study. Post surgical treatment consists of 6 weeks of chemotherapy (TMZ) and radiation followed by a washout period. After Screening and informed consent, patients will undergo apheresis at the study site for collection of peripheral blood mononuclear cells (PBMCs). Apheresis product will be sent to a central site where monocytes will be purified and cultured into dendritic cells (DC). DC will be pulsed with synthetic peptides that correspond to immunogenic epitopes of tumor antigens. The pulsed dendritic cells will then be aliquoted and frozen before shipping back to the site. Patients will have the autologous DCs reinfused intradermally. A control group will receive unpulsed autologous DC. Patients will be randomized by age in a 2:1 ratio to ICT-107 or control.Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional vaccine during a maintenance phase. The primary objective is to compare overall survival (OS) and progression free survival (PFS) in patients when treated with ICT-107 versus Control.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Glioblastoma Multiforme
Intervention ^ICMJE	Biological: ICT-107 Autologous dendritic cells pulsed with immunogenic antigens Biological: Placebo DC Autologous dendritic cells (DC) that have not been pulsed with antigens
Study Arm (s)	Experimental: ICT-107 Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens Intervention: Biological: ICT-107 Placebo Comparator: Placebo Autologous dendritic cells that have not been pulsed with antigens Intervention: Biological: Placebo DC
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Completion Date	Not Provided
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. ≥ 18 years of age HLA-A1 or HLA-A2 positive KPS score of ≥ 70% Baseline hematologic studies and chemistry profiles must meet the following criteria: Hemoglobin (Hgb) > 9.9 g/dL total granulocyte count > than 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) ≤ 1.6x 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) Sufficient paraffin embedded tumor sample for analysis MGMT methylation status Written informed consent, Release of Medical Records Form and Health Insurance Portability and Accountability Act (HIPAA) reviewed and signed by patient or legally authorized representatives Exclusion Criteria: Recurrent disease 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) Severe pulmonary, cardiac or other systemic disease Congestive heart failure Class III or IV according to New York Heart Association (NYHA) 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 (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness Breastfeeding Received any other therapeutic investigational agent within 30 days of enrollment Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01280552
Other Study ID Numbers ^ICMJE	ICT-107-201
Has Data Monitoring Committee	Yes
Responsible Party	ImmunoCellular Therapeutics, Ltd.
Study Sponsor ^ICMJE	ImmunoCellular Therapeutics, Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ImmunoCellular Therapeutics, Ltd.
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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