Clinical trial NCT00093613 (phase 1, status: completed)
Conditions: adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor
ICD codes: C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66, C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        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)