Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Malignant Neoplasms of Brain
MeSH terms: Glioblastoma; Neoplasms; Brain Neoplasms
Intervention: PEP-3 vaccine; sargramostim; Temozolomide
Intervention description: Given intradermally; Given intradermally; Standard of care chemotherapy
Intervention MeSH terms: Temozolomide; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma

Summary:

      RATIONALE: Vaccines made from a peptide may help the body build an effective immune response
      to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white
      blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy
      after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
      with newly diagnosed glioblastoma multiforme.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed newly diagnosed glioblastoma multiforme

          -  Has undergone prior gross total resection (GTR) followed by conformal radiotherapy*
             with or without concurrent chemotherapy

               -  GTR is defined as ≥ 95% volumetric resection of the contrast-enhancing component
                  on the preoperative MRI

               -  Residual radiographic contrast enhancement on post-resection CT scan or MRI must
                  be ≤ 1 cm in maximal diameter in any two perpendicular axial planes

               -  No evidence of disease progression after completion of radiotherapy* NOTE:
                  *Patients may enroll in part 2 of the study within 2 weeks after surgery; these
                  patients will receive radiotherapy with concurrent chemotherapy during the study

          -  EGFRvIII-positive tumor by immunohistochemistry, polymerase chain reaction, or related
             molecular techniques

          -  Karnofsky performance status 80-100%

          -  Curran group status I-IV

          -  Signed informed consent form

        Exclusion Criteria:

          -  Absolute Neutrophil Count (ANC) < 1,000/mm³

          -  Platelet count < 50,000/mm³

          -  Prothrombin Time/Partial Thromboplastin Time (PT/PTT) > 1.5 times normal

          -  Positive hepatitis B (HB) surface antigen (HbsAg), antibody to hepatitis B surface
             antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc)

          -  Pregnant or nursing

          -  Positive pregnancy test

          -  Active infection requiring treatment

          -  Unexplained febrile illness (T max > 101.5 F)

          -  Inflammatory bowel disease, lupus erythematosus, rheumatoid arthritis, or other
             autoimmune disease

          -  Known immunosuppressive disease

          -  Known HIV infection

          -  Diffuse leptomeningeal disease

          -  Unstable or severe concurrent medical condition, such as severe heart and lung disease
             or active hepatitis

          -  Demonstrated allergy to temozolomide or inability to tolerate temozolomide for reasons
             other than lymphopenia

          -  Concurrent corticosteroids (except for nasal or inhaled steroids) at a dose above
             physiologic levels (> 2 mg of dexamethasone/day).