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Status:

COMPLETED

AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: AEE788 and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving AEE788 together with everolim...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of AEE788 when administered in combination with 1 of 2 different doses of everolimus in patients with recurrent ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed glioblastoma multiforme, meeting 1 of the following criteria:
  • Phase I
  • In first or second recurrence or relapse
  • At least 1 measurable or evaluable enhancing lesion by gadolinium MRI (Gd-MRI) of the brain within the past 3 weeks
  • Phase II, group 1
  • In first or second recurrence or relapse by Gd-MRI of the brain within the past 3 weeks
  • Requires tumor biopsy OR surgical resection for tumor debulking or for confirmation of recurrence
  • Phase II, group 2
  • In first recurrence or relapse
  • At least 1 bidimensionally measurable enhancing lesion (≥ 1.5 cm\^2 using product of the largest perpendicular diameters) by Gd-MRI of the brain within the past 3 weeks
  • Multifocal disease allowed
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Karnofsky 70-100%
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No acute or chronic liver disease
  • Renal
  • Total calcium (corrected) normal\*
  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min
  • No proteinuria by dipstick OR
  • Total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min by 24-hour urine collection
  • No acute or chronic renal disease NOTE: \*Supplements allowed
  • Cardiovascular
  • LVEF ≥ 45% by MUGA or echocardiogram
  • No complete left bundle branch block
  • No requirement for a cardiac pacemaker
  • No congenital long QT syndrome
  • No ventricular or atrial tachyarrhythmias
  • No clinically significant resting bradycardia, defined as \< 50 beats per minute
  • QTc ≤ 480 msec by ECG
  • No right bundle branch block and left anterior hemiblock (bifascicular block)
  • No uncontrolled hypertension OR history of labile hypertension
  • No unstable angina pectoris OR angina pectoris occurrence within the past 3 months
  • No congestive heart failure
  • No acute myocardial infarction within the past 3 months
  • No history of poor compliance with an antihypertensive regimen
  • No other impaired cardiac function or clinically significant cardiac disease
  • Gastrointestinal
  • No unresolved diarrhea ≥ grade 2
  • No impairment of gastrointestinal (GI) function or GI disease that would significantly alter absorption of study drugs, including any of the following:
  • Ulcerative disease
  • Uncontrolled nausea
  • Vomiting
  • Malabsorption syndrome
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • Potassium normal\*
  • Magnesium normal\*
  • Phosphorus normal\*
  • Cholesterol ≤ 300 mg/dL (treatment allowed)
  • Triglycerides ≤ 2.5 times ULN (treatment allowed)
  • No known HIV positivity
  • No peripheral neuropathy ≥ grade 2
  • No uncontrolled diabetes
  • No active or uncontrolled infection
  • No other severe and/or uncontrolled medical condition that would preclude study participation or compliance
  • No contraindication to MRI, including any of the following:
  • Cardiac pacemaker
  • Ferromagnetic metal implants other than those approved as safe for use with magnetic resonance scanners (e.g., some types of aneurysm clips or shrapnel)
  • Claustrophobia
  • Obesity exceeding magnetic resonance equipment limits
  • No other clinically significant primary malignancy requiring active intervention NOTE: \*Supplements allowed
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 2 weeks since prior hematopoietic colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa
  • More than 2 weeks since prior immunotherapy and recovered
  • No concurrent biologic therapy
  • No concurrent prophylactic hematopoietic growth factors (e.g., G-CSF or GM-CSF) unless approved by the study sponsor
  • Chemotherapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Must be on stable or deceasing doses of steroids for at least 7 days before baseline Gd-MRI of the brain and before starting study drug
  • No concurrent tamoxifen
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • Surgery
  • More than 1 week since prior tumor biopsy
  • More than 2 weeks since prior surgical resection
  • More than 2 weeks since prior major non-CNS surgery and recovered
  • No prior small bowel resection
  • Other
  • At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsant drugs
  • More than 4 weeks since prior investigational drugs and recovered
  • No prior epidermal growth factor receptor- or ErbB-2-directed therapy (phase II only)
  • No prior vascular endothelial growth factor (VEGF) or VEGF receptor-directed therapy (phase II only)
  • No prior mTOR-directed therapy (phase II only)
  • No concurrent therapeutic warfarin
  • No concurrent treatment with any medication that may prolong QT interval, including any of the following:
  • Quinidine
  • Procainamide
  • Disopyramide
  • Amiodarone
  • Sotalol
  • Bretylium
  • Ibutilide
  • Thioridazine
  • Mesoridazine
  • Chlorpromazine
  • Amitriptyline
  • Imipramine
  • Desipramine
  • Doxepin
  • Erythromycin
  • Clarithromycin
  • Ketoconazole
  • Halofantrine
  • Quinine
  • Chloroquine
  • Mefloquine
  • Moxifloxacin
  • Gatifloxacin
  • Pimozide
  • Risperidone
  • Ziprasidone
  • Venlafaxine
  • Maprotiline
  • Lithium
  • Pentamidine
  • Droperidol
  • Dolasetron
  • No concurrent digoxin or verapamil
  • No concurrent tacrolimus
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2006

    Estimated Enrollment :

    16 Patients enrolled

    Trial Details

    Trial ID

    NCT00107237

    Start Date

    October 1 2003

    End Date

    June 1 2006

    Last Update

    June 12 2013

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    2

    Duke Univaersity Medical Center

    Durham, North Carolina, United States, 27710

    3

    MD Anderson Cancer Center/University of Texas

    Houston, Texas, United States, 77030