Study of LBH589 (Panobinostat) to Treat Malignant Brain Tumors

NCT00848523 | Terminated Phase 2 DMC

• 1 other identifier: LIBTC-2008-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The drug LBH589 (panobinostat) is an experimental (investigational) drug that is being tested for recurrent (returning) malignant gliomas. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). It belongs to a new class of drugs called "histone deacetylase inhibitors." Histones are proteins located in the nucleus of cells that bind to DNA, the chemical that makes up genes. These proteins help control which genes are turned "on" and "off." Studies have shown that drugs like panobinostat (LBH589) may lead to tumor cell death.

Conditions

Recurrent Malignant Gliomas

Keywords

LBH859; Panobinostat; GBM; Glioma; Glioblastoma; Astrocytoma; oligodendroglioma; oligoastrocytoma; gliosarcoma; anaplastic

Outcome Measures

Primary Outcomes (1)

• To generate preliminary data of anti-tumor efficacy of LBH589 in adults with recurrent malignant gliomas.

  12 months

Secondary Outcomes (2)

• To determine primary efficacy endpoint PFS-6

  6 months

• To determine objective response (CR + PR) Rate

  12 months

Interventions

Panobinostat DRUG

30 mg, three times a week, patients will continue with treatment until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.

Also known as: LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Surgery, P.C.: lead

Study Sites (2)

Long Island Brain Tumor Center at Neurological Surgery PC / Long Island Neuro-Oncology Associates

Commack, New York, 11725, United States

Location

Long Island Brain Tumor Center at Neurological Surgery PC / Long Island Neuro-Oncology Associates

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma; Gliosarcoma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• J. Paul Duic, MD

  Long Island Brain Tumor Center at Neurological Surgery PC / Long Island Neuro-Oncology Associates

  PRINCIPAL INVESTIGATOR

• Jai Grewal, MD

  Long Island Brain Tumor Center at Neurological Surgery PC/ Long Island Neuro-oncology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 16, 2010

Record last verified: 2009-09

Locations

US (2)