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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

Phase 2
18 Years
80 Years
Open (Enrolling)
Glioblastoma Multiforme

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Trial Information

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

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.

Inclusion Criteria:

1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and
not yet received chemoradiation.

2. ≥ 18 years of age

3. HLA-A1 or HLA-A2 positive

4. KPS score of ≥ 70%

5. 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

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. Sufficient paraffin embedded tumor sample for analysis MGMT methylation status

9. 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:

1. Recurrent disease

2. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife
and placement of Gliadel wafer

3. Presence of any other active malignancy or prior history of malignancy (except for
basal cell carcinoma of the skin)

4. Severe pulmonary, cardiac or other systemic disease

5. Congestive heart failure Class III or IV according to New York Heart Association

6. Presence of an acute infection requiring active treatment with
antibiotics/antivirals; prophylactic administration is allowed

7. Known history of an autoimmune disorder

8. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency
syndrome (AIDS) related illness or other serious medical illness

9. Breastfeeding

10. Received any other therapeutic investigational agent within 30 days of enrollment

11. Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to
the first administration of study vaccine

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Description:

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)

Outcome Time Frame:

2 -3 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Glioblastoma



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