Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: poly ICLC; temozolomide; radiation therapy
Intervention description: 20 mcg/kg 3x each week (Maintenance cycles); daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant); RT: 60 Gy (6 weeks) concomitant therapy
Intervention MeSH terms: Temozolomide; Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Biological therapies, such as
      poly ICLC, may stimulate the immune system in different ways and stop tumor cells from
      growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining
      tumor cells from growing.

      PURPOSE: This phase II trial is studying how well giving radiation therapy together with
      temozolomide followed by temozolomide and poly ICLC works in treating patients with newly
      diagnosed glioblastoma multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
             by biopsy or resection within the past 3 months

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status ≥ 60%

          -  Absolute neutrophil count ≥ 1500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 mg/dL

          -  Transaminases ≤ 4 times above the upper limits of the institutional normal

          -  Creatinine ≤ 1.7 mg/dL

          -  Not pregnant or breast-feeding

          -  Patients must agree to follow acceptable birth control methods to avoid conception

          -  Negative pregnancy test

          -  Patients must have a Mini Mental State Exam score of ≥ 15

          -  No serious concurrent infection or medical illness which would jeopardize the ability
             of the patient to receive the treatment outlined in this protocol with reasonable
             safety

          -  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 ≥ five years
                  are eligible for this study

          -  Patients requiring ongoing therapy for psychoses with antipsychotic medications at the
             time of enrollment will be ineligible

        PRIOR CONCURRENT THERAPY:

          -  Patients must not have received prior radiation therapy, chemotherapy, immunotherapy
             or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense,
             peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or
             hormonal therapy for their brain tumor

               -  Prior glucocorticoid therapy is allowed

          -  Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy
             against the tumor while being treated with poly ICLC plus temozolomide on this
             protocol

          -  No other concurrent therapy for their tumor (i.e., chemotherapeutics or
             investigational agents)

          -  Patients who have received prior Gliadel wafers are not eligible for this study

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  No concurrent electron, particle, implant, or stereotactic radiosurgery boost