Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
Condition: CNS Cancer; CNS BRAIN
MeSH terms: Oligodendroglioma
Intervention: temozolomide followed by high dose busulfan and thiotepa
Intervention description: Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion
Intervention MeSH terms: Temozolomide; Busulfan; Thiotepa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Healthy volunteers: No
Keywords: Brain; CNS; TEMOZOLOMIDE; Busulfan; Thiotepa

Summary:

      The purpose of this study is to see how effective treatment of high doses of chemotherapy is
      for your tumor. We will also be looking at the side effects and risks of this treatment.

      You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy
      tumor cells, but it can also destroy normal bone marrow cells. These cells produce white
      blood cells (which fight infection), red blood cells (which carry oxygen) and platelets
      (which allow your blood to clot). With too few of these cells there is a serious risk of
      infection and bleeding.

      Therefore, before treatment begins, we will collect some of your own blood cells, called
      peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs
      are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs
      are thawed and given back to you. These healthy PBPCs will replace the blood cells that the
      high dose chemotherapy destroys and allow your bone marrow to recover and produce blood
      cells. In a prior study we treated 69 patients in a similar way. More than half were able to
      avoid or delay brain radiation. This new study will use a different high dose chemotherapy
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health
             Organization classification criteria will be used. Central pathology review must take
             place prior to high-dose therapy but need not occur prior to study entry and induction
             therapy.

          -  Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again,
             histopathologic diagnosis will be made using World Health Organization classification
             criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial
             element. Central pathology review must take place prior to high-dose therapy but need
             not occur in advance of enrollment or induction therapy.

          -  The diagnostic surgical procedure may have been a complete resection, partial
             resection, or biopsy.

          -  Karnofsky performance status > or equal to 60.

          -  Granulocyte count > or equal to 1.5 X 109/L.

          -  Platelet count > or equal to 100 X 109/L

          -  SGOT < than or equal to 2X upper limit of normal.

          -  Serum creatinine < than or equal to 1.5X upper limit of normal

          -  Bilirubin < than or equal to 1.5X upper limit of normal

          -  All patients must sign written informed consent.

        Exclusion Criteria:

          -  Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)

          -  Prior cranial radiotherapy or systemic chemotherapy

          -  Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal
             cell carcinoma of the skin) or serious illness if this would interfere with the
             prescribed treatment.

          -  Pregnant or lactating women

          -  Refusal to use effective contraception