LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Patrick Y. Wen, MD
Study ID
NCT00859222
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.

Key Dates

First listed
Mar 10, 2009
Start date
Mar 31, 2009
Status verified
Feb 2017
Primary completion
Sep 30, 2013
Completion
Dec 31, 2015

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Cohort 1: Bevacizumab +LBH589 20 mg every week
    Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: Phase I Cohort 2: Bevacizumab + LBH589 20 mg every other week
    Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: Phase I Cohort 3: Bevacizumab + LBH589 30 mg every other week
    Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: All Phase I Participants
    All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: Phase II GBM: Bevacizumab + LBH589 30 mg every other week
    Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: Phase II AG: Bevacizumab + LBH589 30 mg every other week
    Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
  • Experimental: All Phase II Participants
    All phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.

Primary Outcome Measure

LBH589 Maximum Tolerated Dose (MTD) [Phase I] [ Time Frame: Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Beth-Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Virginia, Department of NeurologyCharlottesvilleVirginia22908-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILBeth-Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Virginia, Department of Neurology· Charlottesville, VA

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