A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: ICT-107; Placebo DC
Intervention description: Autologous dendritic cells pulsed with immunogenic antigens; Autologous dendritic cells (DC) that have not been pulsed with antigens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Glioblastoma Multiforme

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.
    

Eligibility criteria:

        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
             (NYHA)

          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