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|NCT02546102 : Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
1. Subjects must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central
4. Subjects must be HLA-A2 positive by central lab
5. Subjects must have adequate renal, hepatic and bone marrow function based on
screening laboratory assessments. Baseline hematologic studies and chemistry and
coagulation profiles must meet the following criteria:
1. Hemoglobin (Hgb) > 8 g/dL
2. Absolute Neutrophil Count (ANC) > 1000/mm3
3. Platelet count > 100,000/mm3
4. Blood Urea Nitrogen (BUN) < 30 mg/dL
5. Creatinine < 2 mg/dL
6. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine
Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
7. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x
unless therapeutically warranted
6. Subjects must use effective contraceptive methods during the study and for three
months following the last dose of study product, if of reproductive age and still
retain fertility potential.
7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test
item challenge prior to randomization.
1. Subjects receiving investigational study drug for any indication or
immunological-based treatment for any reason (Filgrastim may be used for prevention
of severe neutropenia).
2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3. Subjects with concurrent conditions that would jeopardize the safety of the subject
or compliance with the protocol.
4. Subjects with a history of chronic or acute hepatitis C or B infection.
5. Subjects require or are likely to require more than a 2-week course of
corticosteroids for intercurrent illness. Subjects must have completed the course of
corticosteroids at the time of apheresis to meet eligibility.
6. Subjects have any acute infection that requires specific therapy. Acute therapy must
have been completed within seven days prior to study enrollment.
7. Subjects with active other malignancy diagnosed in the past 3 years (excepting in
8. Subjects known to be pregnant or nursing.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02546102
| Link to official Clinicaltrials.gov listing