Clinical trial NCT00045708 (phase 1/phase 2, status: completed)
Conditions: adult anaplastic astrocytoma, 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, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: ixabepilone, anticonvulsant
SMILES: [H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically proven malignant glioma (anaplastic astrocytoma or
             glioblastoma multiforme) which is progressive or recurrent following 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

          -  Patients must have recovered from severe 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

          -  HgB > 9 g/dl

          -  Creatinine =< 1.5mg/dl

          -  Total Bilirubin =< 1.5mg/dl

          -  Transaminases =< 2.5 times above the upper limits of the institutional norm)

          -  Patients must be able to provide written informed consent

          -  Patients must have =< 2 prior chemotherapy regimens

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

          -  Patients must have no concurrent malignancy except curatively treated basal or
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast;
             patients with prior malignancies must be disease-free for >= five years

          -  Patients must be maintained on a stable corticosteroid regimen from the time of their
             baseline scan until the start of treatment

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

          -  Patients who are pregnant or breast-feeding

          -  Patients with more than 2 prior chemotherapy regimens

          -  Patients receiving concurrent investigational agents

          -  Patients receiving any of the following medications which are known to be moderate to
             significant inhibitors of CYP3A4 are not eligible:

               -  Antibiotics: clarithromycin, erythromycin, troleandomycin

               -  Anti-HIV agents: delavirdine, nelfinavir, amprenavir, ritonavir, indinavir,
                  saquinavir, lopinavir

               -  Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200mg/day),
                  voriconazole

               -  Antidepressants: nefazodone, fluvoxamine

               -  Calcium channel blockers: verapamil, diltiazem

               -  Miscellaneous: amiodarone NOTE: The above list of agents was provided by the
                  National Cancer Institute as moderate to significant inhibitors of CYP3A4 that
                  should not be administered with BMS; there may be other agents that have similar
                  activities on CYP3A4, however these are currently unspecified; if investigators
                  are concerned about a particular medication's inhibitory effect on CYP3A4, they
                  are encouraged to consult local pharmacy services for more information and to
                  contact the principal investigator to discuss the situation further