A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma

Inclusion Criteria:

- Patients must have histologically proven malignant glioma (anaplastic astrocytoma,
anaplastic oligodendroglioma or glioblastoma multiforme) which is progressive or
recurrent after radiation therapy ± chemotherapy; patients with previous low grade
glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to
have a high grade glioma are eligible

- Patients must have measurable progressive or recurrent malignant glioma by MRI or CT
imaging; (Within 14 days before starting treatment)

- Patients must have recovered from toxicity of prior therapy; an interval of at least
3 months must have elapsed since the completion of the most recent course of
radiation therapy, while at least 3 weeks must have elapsed since the completion of a
non-nitrosourea containing chemotherapy regimen, and at least 6 weeks since the
completion of a nitrosourea containing chemotherapy regimen

- Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be
able to care for himself/herself with occasional help from others)

- Absolute Neutrophil Count >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Creatinine =< 1.7mg/dl

- Total Bilirubin =< 1.5mg/dl

- Transaminases =< 4 times above the upper limits of the institutional norm

- PT, PTT, INR within institutional norm

- Patients must be able to provide written informed consent

- Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception; women of childbearing
potential must have a negative serum pregnancy test; (The anti-proliferative activity
of this experimental drug may be harmful to the developing fetus or nursing infant)

- Patients must have a Mini Mental State Exam score >= 15

Exclusion Criteria:

- Patients with serious concurrent infection or medical illness which would jeopardize
the ability of the patient to receive the treatment outlined in this protocol with
reasonable safety; (Examples of medical illnesses are [but not limited to] the
following: uncontrolled hypertension, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that
would limit compliance with study requirements)

- Patients who are pregnant or breast-feeding; (The anti-proliferative activity of this
experimental drug may be harmful to the developing fetus or nursing infant)

- Patients who have received more than two prior treatments

- Patients receiving concurrent therapy for their tumor (with the exception of
steroids)

- Patients with a concurrent malignancy are ineligible unless they are patients with
curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients
with a prior malignancy are ineligible unless they have been free of disease for >=
five years

- Patients must not have any evidence of bleeding diathesis

- Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation
(i.e. low dose warfarin) of venous or arterial access devices is allowed provided
that the requirements for PT, INR or PTT are met; (Patients will be taken off
treatment if they require therapeutic anticoagulation during BAY 43-9006 treatment)