ICT-107 is an experimental “vaccine” for the treatment of GBM.  It is thought to work by “teaching” the immune system to recognize and destroy GBM tumor cells.  This is accomplished by harvesting special immune cells known as dendritic cells from the patient, “programming” them to attack tumor-specific antigens, and then injecting them back into the patient’s body.

In an earlier Phase I clinical study, GBM patients who received ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy had significantly longer disease-free survival (meaning the time from surgery to tumor recurrence) than is typically expected with standard treatment alone.  Mild side effects such as fatigue and rash, redness and itching at the site of injection were observed.  For more detailed Phase I clinical data, please click here.http://www.imuc.com/imuc-09-08-2010

About the Phase II study

We are conducting a double-blind, placebo-controlled, multi-center, randomized Phase II study that is designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study will enroll approximately 100 evaluable patients and will be conducted at an estimated 15 – 20 clinical trial centers in the U.S.   

For more information on this study, please visit
http://clinicaltrials.gov/ct2/show/NCT01280552?term=ICT-107&rank=1

 

Enrollment criteria

Eligible patients for this study must:

• Have newly diagnosed, Stage IV glioblastoma multiforme (GBM)
• Have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment in the study

 

Patients who have already started radiation and chemotherapy will not be eligible for this trial. 

For more information on enrollment criteria, please visit [clinicaltrials.gov site]

Is this clinical study right for me?

 If you believe you meet the enrollment criteria described above, please talk to your doctor about whether this clinical study is right for you.  To help you and your doctor make a well-informed decision, please click here to download a fact sheet, which contains key information about the clinical study.

 How do I enroll?

To enroll in the study, please contact the study center closest to you. For more information, please email or call 818-992-2907. Additional contacts:

Kate Whicher      508-597-5873           kate.whicher@averionintl.com

Resources

Clincaltrials.gov
National Brain Tumor Foundation
American Brain Tumor Association
Musella Foundation
National Cancer Institute