Clinical trial NCT00848523 (phase 2, status: terminated)
Conditions: recurrent malignant gliomas
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: panobinostat
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Reason stopped: 
    insufficient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent malignant glioma with radiographic progression

          -  No more than three prior therapies.

          -  Male or female patients >=18 years old

          -  KPS >=60.

          -  Ability to provide written informed consent or consent obtained from responsible
             healthcare proxy.

          -  Contrast-enhanced MRI within 2 weeks of enrollment.

          -  Life expectancy >= 8 weeks

          -  Neutrophils >1500/mm3

          -  Platelets > 100,000/mm3L

          -  Hemoglobin >=9 g/dL

          -  AST/SGOT and ALT/SGPT <= 2.5 x upper limit of normal (ULN) or < 5.0 x ULN if the
             transaminase elevation is due to disease involvement

          -  Serum bilirubin <= 1.5 x ULN

          -  Serum creatinine <= 1.5 x ULN or 24-hour creatinine clearance >= 50 ml/min

          -  Total serum calcium or ionized calcium WNL

          -  Serum potassium WNL

          -  Serum sodium WNL

          -  Serum albumin >= LLN or 3g/dl

          -  Elevated Alkaline Phosphatase due to bone metastasis can be enrolled

          -  Baseline MUGA or ECHO must demonstrate LVEF >= the LLN

          -  TSH and free T4 WNL (patients may be on thyroid hormone replacement)

          -  Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             within 7 days of the first administration of study treatment and must be willing to
             use two methods of contraception one of them being a barrier method during the study
             and for 3 months after last study drug administration.

          -  No concurrent antitumor therapy.

          -  No enzyme-inducing antiepileptic drugs.

          -  No significant comorbidities

          -  Patients must have recovered from toxic effects of prior therapy.

        Exclusion criteria

          -  Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer

          -  Valproic acid for any medical condition during the study or within 5 days prior to
             first LBH589 treatment

          -  Impaired cardiac function including:

          -  Screening ECG with a QTc > 450 msec

          -  Congenital long QT syndrome

          -  History of sustained ventricular tachycardia

          -  History of ventricular fibrillation or torsades de pointes

          -  Bradycardia < 50 beats per minute. Patients with a pacemaker and heart rate > = 50
             beats per minute are eligible.

          -  Myocardial infarction or unstable angina within 6 months

          -  Congestive heart failure (NYHA class III or IV)

          -  RBBB and LAH (bifascicular block)

          -  Uncontrolled hypertension

          -  Concomitant use of drugs with a risk of causing torsades de pointes Concomitant use of
             CYP3A4 inhibitors

          -  Patients with unresolved diarrhea

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter absorption of LBH589

          -  Concurrent severe and/or uncontrolled medical conditions

          -  Chemotherapy, any investigational drug or major surgery < 4 weeks prior to starting
             study drug or have not recovered from side effects of such therapy.

          -  Concomitant use of any anti-cancer therapy or radiation therapy.

          -  Women who are pregnant or breast feeding or women of childbearing potential (WOCBP)
             not willing to use a double barrier method of contraception during the study and 3
             months after the end of treatment. One of these methods of contraception must be a
             barrier method.

          -  Male patients whose sexual partners are WOCBP not using a double method of
             contraception during the study and 3 months after the end of treatment. One of these
             methods must be a condom

          -  History of another primary malignancy within 5 years other than curatively treated CIS
             of the cervix, or basal or squamous cell carcinoma of the skin

          -  Known human immunodeficiency virus (HIV) or hepatitis C positivity

          -  Significant history of non-compliance to medical regimens or inability to grant a
             reliable informed consent

          -  More than three prior therapies

          -  Hepatic or renal diseases or any diseases that will obscure toxicity or alter drug
             metabolism

          -  Known active malignancies

          -  Active infection requiring iv antibiotics

          -  Systemic anticoagulants

          -  Enzyme-inducing antiepileptic drugs