This phase II trial studies the side effects and how well vaccine therapy works when given
together with temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines
made from the survivin peptide or antigen may help the body build an effective immune
response to kill tumor cells that express survivin. Drugs used in chemotherapy, such as
temozolomide, work in different ways to stop the growth of tumor cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet
known whether temozolomide is more effective with or without vaccine therapy in treating
glioblastoma.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Have a Karnofsky performance status >= 70 (i. e. the patient must be able to care for
himself/herself with occasional help from others)
- Documented survivin-positive tumor status
- Pathologically confirmed diagnosis of glioblastoma multiforme (GBM)
- Absolute neutrophil count (ANC) >= 1. 5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Hemoglobin (Hgb) > 9. 0 g/dL
- Serum total bilirubin: =< 1. 5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 4. 0 x ULN
- Blood coagulation parameters: international normalized ratio (INR) =< 1. 5 for
patients not on warfarin
- Patients on full-dose anticoagulants (e. g., warfarin or low molecular weight [LMW]
heparin must meet both of the following criteria:
- No active bleeding or pathological condition that carries a high risk of
bleeding (e. g., tumor involving major vessels or known varices)
- In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a
stable dose of low molecular weight heparin
- Creatinine =< 1. 8 mg/dl
- Human leukocyte antigen (HLA)-A*02, HLA-A*03, HLA-A*11 and HLA-A*24 positive patients
- No evidence of progressive disease from the postoperative period to the
post-chemoradiation period, based on changes in the neurologic exam steroid use, or
evident radiographic progression, according to RANO criteria
- Magnetic resonance imaging (MRI) (ideally completed within 72 hours after surgery)
documenting gross total resection consisting of no gadolinium enhancement; or
subtotal resection consisting of linear enhancement with (or without) nodular
gadolinium enhancement measuring no greater than 1 cm x 1 cm x 1cm total volume or
100 mm^2 in cross sectional area
- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e. g., hormonal or barrier method of birth control; abstinence) prior to
study entry, and have a negative pregnancy test prior to starting study treatment;
should a woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately
- Dexamethasone dose less than or equal to 4 mg daily at time of study enrollment
- Patients must have completed initial radiation therapy (RT) and temozolomide (TMZ)
for the treatment of their glioblastoma (i. e., completed 6-week course of RT and,
completed >= 75% of 6-week course of induction TMZ chemotherapy)
- Participant or legal representative must understand the investigational nature of
this study and sign an Independent Ethics Committee/Institutional Review Board
approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- The patient must not have received any immunotherapy for their brain tumor
- Patients with serious concurrent infection or medical illness, which in the treating
physicians opinion would jeopardize the ability of the patient to receive the
treatment outlined in this protocol with reasonable safety
- Patients who are pregnant or breast-feeding
- Patients receiving concurrent therapy for their tumor (i. e. chemotherapeutics or
investigational agents) other than temozolomide
- Patients with a concurrent or prior malignancy are ineligible unless they are
patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the
skin; patients who have been free of disease (any prior malignancy) for at least 3
years are eligible for this study
- Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ
treatment
- Patients who received other chemotherapeutics or investigational agents in addition
to their radiation therapy and concomitant temozolomide treatment
- Patients who have received Gliadel wafers or alternating electrical field therapy
(ETTF) are not eligible for this study
- Known history of an autoimmune disorder
- Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency
syndrome (AIDS) related illness or other serious medical illness
- Patients who have contraindication to MRI
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate to receive study drug
- Received an investigational agent within 30 days prior to registration