A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.
for cancer, but they have not been tested together for brain cancer.
3. What side effects does the combination of drugs cause?
they are able to do)?
astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
- Subjects are allowed to have previous chemotherapy for their tumors.
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.
SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.
in the STEP program for thalidomide.
- Prior therapy with either irinotecan or thalidomide.
- Oxygen saturation 90% on room air.
- Cardiac insufficiency at New York Heart Association status 2 or greater.
situ cervical and breast lesions.
consent or compliance with protocol requirement.
- Known hypersensitivity or allergic reaction to study drug.
- Women at any stage of pregnancy.