Clinical trial NCT01095094 (phase 2, status: terminated)
Conditions: brain tumor, anaplastic astrocytoma, anaplastic ependymoma, anaplastic oligodendroglioma, brain stem glioma, giant cell glioblastoma, glioblastoma, gliosarcoma, mixed glioma
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6, C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66
Drugs: ritonavir, lopinavir
SMILES: CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1, CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1
Reason stopped: 
    study did not meet its primary objective
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven high grade glioma (WHO grade 3-4) which is progressive or
             recurrent following radiation therapy with or without chemotherapy

          -  Patients with previous low grade glioma who progressed after radiotherapy and
             chemotherapy and are biopsied and found to have a high grade glioma are eligible

          -  Patients must have recovered from toxicity of prior therapy - An interval of >= 3
             months must have elapsed since the completion of the most recent course of radiation
             therapy

          -  Minimum interval since last drug therapy: 2 weeks since last non-cytotoxic therapy; 3
             weeks must have elapsed since the completion of a non-nitrosourea containing
             chemotherapy regimen; 6 weeks since the completion of a nitrosourea containing
             chemotherapy regimen

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

          -  Patients must have normal hematologic, renal, and liver function (i.e., absolute
             neutrophil count >= 1500/mm^3, platelets >= 100,000/mm^3, HgB > 9 d/dl, creatinine =<
             1.5mg/dl, total bilirubin =< 1.5mg/dl, transaminases =< 2.5 times the upper limits of
             the 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 contraception - 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 of carcinoma in situ of the cervix and breast,
             adequately treated stage I or II cancer from which the patient is in complete
             remission

          -  Patients with other prior malignancies must be disease-free for >= 3 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 >= 15

        Exclusion Criteria:

          -  Patients with serious concurrent infection or medical illness, which would jeopardize
             the ability of the patient to receive the treatment outlines in this protocol with
             reasonable safety

          -  Patients who are pregnant or breast-feeding

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

          -  HIV positive

          -  Prior therapy with HIV protease inhibitors

          -  Concurrent therapy with hepatic enzyme inducing anticonvulsant

          -  Inability to be followed closely at the Cleveland Clinic

          -  Patients requiring the use of medication well-known contraindicated for concomitant
             use with lopinavir/ritonavir: amiodarone, astemizole, bepridil, bupropione, cisapride,
             clorazepate, clozapim, diazepam, encainide, flecainide, flurazepam, meperidine,
             midazolam, primozide, piroxicam, propafenone, propoxifeno, quinidine, rifabutin,
             terfenadine, triazolam, zolpidem, dihydroergotamine, ergotamine