A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
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