A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer
Inclusion Criteria:
- Histologic confirmation of non-small-cell lung cancer
- Stable systemic disease
- Maximum of one prior chemotherapy regimen for metastatic systemic disease
- Radiotherapy for local control or palliative bony lesions is allowed
- Karnofsky of greater than or equal to 70%
- Adequate hematologic, renal and liver function
Exclusion Criteria:
- Patients eligible for surgery of the brain
- Any previous chemotherapy for the brain metastasis
- Chemotherapy within 4 weeks or previous temozolomide
- Prior radiotherapy to the brain
- Radiation therapy to greater than 50% of the bone marrow
- Insufficient recovery from previous therapies
- Active nonmalignant systemic disease
- Inability to take oral medication
- Pregnant or nursing women
- Non use of adequate contraceptive techniques, negative urine pregnancy test is
required
- Known AIDS related illness