A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors

Inclusion Criteria

• •Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
• •Subjects are allowed to have definitive surgery and/or radiation treatment to their tumors.
• •Subjects are allowed to have previous chemotherapy for their tumors.
• •Subjects who previous diagnosed to have a low grade lesion need a second biopsy to show transformation into a high grade histology.
• •Subjects need to have radiographic or biopsy proven recurrent disease.
• •ECORT performance status 2 or lower. See appendix I.
• •Baseline laboratory values within 30 days of study entry: hemoglobin 10 gm/dl; absolute neutrophil count 1,500 cells/ml; platelet counts 100,000 cells/ml; SGOT/AST, SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.
• •Ability to provide written informed consent.
• •Age \> 18 years.
• •Female patients of childbearing potential must have a documented negative serum pregnancy test within 14 days of study entry.
• •All subjects must agree to use an effective method of contraception for the duration of treatment if engaged in sexual activity where conception is possible, as specified in the STEP program for thalidomide.