Clinical trial NCT01103375 (phase 1, status: terminated)
Conditions: adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult diffuse astrocytoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult mixed glioma, adult oligodendroglioma, 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: erlotinib hydrochloride, isotretinoin
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, C\C(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(O)=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

        Histologically proven malignant glioma (glioblastoma multiforme, anaplastic astrocytoma,
        anaplastic oligodendroglioma, or anaplastic mixed oligoastrocytoma) 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 Karnofsky performance status of >= 60% Patients - both males
        and females - with reproductive potential (i.e., premenopausal or menopausal for less than
        1 year and not surgically sterilized) must practice at least 2 contraceptive measures
        throughout the study Patients must be registered and meet all the requirements of iPLEDGE
        in order to receive 13-cis-Retinoic Acid (CRA) Patients must provide verbal and written
        informed consent to participate in the study Patients must have a Mini Mental Status Exam
        score >= 15 Patients must have a 12-lead electrocardiogram (EKG) without evidence of any
        clinically significant abnormalities Absolute neutrophil count (ANC) >= 1,500/mm^3
        Platelets >= 100,000/mm^3 Aspartate aminotransferase (AST) =< 2.5 upper limit of normal
        (ULN) (ULN = 50 U/L) Alanine aminotransferase (ALT) =< 2.5 ULN (ULN = 50 U/L) Total
        Bilirubin =< 1.5 mg/dL Alkaline phosphatase (Alk. Phos) =< 5X ULN (ULN = 125 U/dL)
        Estimated (Estim.) creatinine (Cr) Clearance > 50 ml/min Fasting total cholesterol < 300
        mg/dL Fasting triglycerides < 250 mg/dL Two separate, laboratory pregnancy tests within 14
        days of registration (for women of childbearing potential) Patients must have recovered
        from the toxicity of prior therapy; specifically, there must be at least a 3 month interval
        from the completion of the most recent course of radiation therapy, at least a 3 month
        interval from the implantation of Gliadel wafer(s), at least a 3 week interval from the
        completion of a non-nitrosourea-containing chemotherapy regimen, and at least a 6 week
        interval from the completion of a nitrosourea-containing chemo-regimen

        Exclusion Criteria:

        Pregnant or breast-feeding women Uncontrolled intercurrent illness including, but not
        limited to, ongoing or active infection, severe cardiovascular disease including recent (<
        6 months) myocardial infarction, severe psychiatric illness that would limit compliance
        with study requirements, or any other disorder that would be incompatible with the study
        therapy Any history of inflammatory bowel disease Any history of uncontrolled depression,
        any history of hospitalization for depression, or any history of suicidal thoughts or
        attempt(s) Patients receiving concurrent therapy for their tumor (with the exception of
        steroids) Must have at least a 10 day interval from last dose of vitamin A, tetracyclines,
        micro-dosed progesterone preparations, norethindrone/ethinyl estradiol, St. John's Wort,
        fish oil supplements, or phenytoin or other P450 enzyme inducing antiepileptic drugs
        Current smokers (Smoking >= 11 cigarettes per day), as smoking increases metabolism and
        decreases serum levels of erlotinib Participants may not have received prior EGFR
        inhibitors for any disease Patients with a history of allergic reactions to 13-cis-retinoic
        acid (CRA) or compounds of similar biologic or chemical composition to CRA Known allergy to
        proton pump inhibitors