A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Inclusion Criteria:

- Patients must have histological or neuroradiographic documented recurrent glioma
defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma.
All patients must have had prior pathologic confirmation of primary tumor histology.

- Patients must be > than or equal to 18 years old.

- Patients must have a Karnofsky performance score (KPS) of > or equal to 50

- Measurable disease per MacDonald criteria is required

- Patients must have a predicted life expectancy of at least 12 weeks

- Required initial laboratory data:

1. Absolute Neutrophil Count (ANC) > 1,500

2. Platelets > 100,000

3. Serum Creatinine < 2.0

4. Serum Bilirubin < 2.0

5. Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal

6. Pregnancy test for females with child-bearing potential negative

- Patients must sign and date an IRB approved informed consent form stating he or she
is aware of the neoplastic nature of the disease. Patient must willingly provide
written consent after being informed of the procedure to be followed, the
experimental nature of the therapy, alternatives, potential benefits, side effects,
risks, and discomforts. (Human protection committee approval of this protocol and
consent form is required).

- Patients must be willing and able to comply with scheduled visits, treatment plan,
and laboratory tests and accessible for follow-up.

- Patients must have been previously treated with both surgery and radiotherapy.

- Prior adjuvant and one salvage chemotherapy regimen is permitted.

- Prior stereotactic radiotherapy is permitted.

Exclusion Criteria:

- Patients have evidence of leptomeningeal spread of disease.

- Patients having been treated with 2 or more salvage regimens.

- Pregnant or breast-feeding women. With the exception of post-menopausal or infertile
women, a negative blood test for pregnancy is mandatory before entry on study.
Fertile persons refusing to use adequate contraceptives may not participate.

- Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic
diarrhea or presence of a bowel obstruction.

- Patients with a second active malignancy or diagnosis of other cancer within 3 years
of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma
of the cervix.

- Mentally incapacitated patients or psychiatric illness that would prevent the patient
from giving informed consent.

- Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high
blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial
infarction within the previous six months, or serious uncontrolled cardiac
arrhythmia.

- Known to be human immunodeficiency virus (HIV) positive or to have an acquired
immunodeficiency syndrome (AIDS) related illness.

- Patients with an active infection that is not adequately controlled with antibiotics.

- Patients with other severe concurrent disease, which, in the judgment of the
investigator, would make the patient inappropriate for entry into this study.

- Patients with a known sensitivity to any of the products to be administered during
treatment.

- Patients currently enrolled in another clinical trial or patients who have
participated in a trial of an investigational device or drug within the last 30 days.

- Patients previously treated with CPT-11.

- Concurrent stereotactic radiotherapy.