SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Condition: Glioblastoma; Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma
Intervention: Laboratory Biomarker Analysis; Montanide ISA 51 VG; Sargramostim; SVN53-67/M57-KLH Peptide Vaccine; Temozolomide
Intervention description: Correlative studies; Given SC; Given SC; Given SC; Given PO or IV
Intervention MeSH terms: Temozolomide; Sargramostim; Monatide (IMS 3015)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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); or World Health
             Organization (WHO) grade IV [gliosarcoma]

          -  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

          -  Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW]
             heparin) must meet 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)

          -  Creatinine =< 1.8 mg/dl

          -  Human leukocyte antigen (HLA)-A*02, HLA-A*03, HLA-A*11 or 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; Patients with increased
             or new gadolinium enhancement may continue on protocol if in the investigator's
             judgment that enhancement is likely due to pseuodoprogresion. The use of correlative
             imaging studies (including PWI) or diffusion weighted imaging (DWI) and repeat imaging
             after an interval of 2-4 weeks is strongly encouraged to help distinguish between
             pseudoprogression and true progression.

          -  Magnetic resonance imaging (MRI) (ideally completed within 96 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 1 cm 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 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
             physician's 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