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Status:

COMPLETED

Imatinib Mesylate, Vatalanib, and Hydroxyurea in Treating Patients With Recurrent or Relapsed Malignant Glioma

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells by...

Detailed Description

OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate and vatalanib when administered with hydroxyurea in patients with recurrent or relapsed grade 3 or 4...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed malignant glioma
  • Grade 3 or 4 disease
  • In first, second, or third recurrence or relapse
  • Multifocal disease allowed
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count \> 1,500/mm\^3
  • Hemoglobin \> 9 g/dL
  • Platelet count \> 100,000/mm\^3
  • Potassium normal\*
  • Total calcium (corrected) normal\*
  • Magnesium normal\*
  • Phosphorus normal\*
  • aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN)
  • Bilirubin \< 1.5 times ULN
  • Negative proteinuria by dipstick OR total urinary protein ≤ 500 mg with creatinine clearance ≥ 50 mL/min by 24-hour urine collection
  • Creatinine \< 1.5 times ULN OR creatinine clearance \> 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No acute or chronic liver or renal disease
  • left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram
  • No complete left bundle branch block
  • No obligate use of a cardiac pacemaker
  • No congenital long QT syndrome
  • No history of or current ventricular or atrial tachyarrhythmias
  • No clinically significant resting bradycardia (i.e., heart rate \< 50 beats/minute)
  • No right bundle branch block with left anterior hemiblock (bifascicular block)
  • No uncontrolled hypertension ≥ grade 2, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  • No concurrent unstable angina pectoris or angina pectoris within the past 3 months
  • No congestive heart failure (CHF)
  • No history of CHF or arrhythmias requiring concurrent digoxin or verapamil
  • No acute myocardial infarction within the past 3 months
  • No other impaired cardiac function or clinically significant cardiac disease
  • No peripheral neuropathy ≥ grade 2
  • No unresolved diarrhea ≥ grade 2
  • No uncontrolled diabetes
  • No active or uncontrolled infection requiring intravenous antibiotics
  • No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib, hydroxyurea, and/or everolimus, including any of the following:
  • Ulcerative disease
  • Uncontrolled nausea, vomiting, or diarrhea
  • Malabsorption syndrome
  • Small bowel resection
  • No other concurrent severe and/or uncontrolled medical condition that would preclude study participation or compliance
  • No known HIV positivity
  • No other primary malignancy that is clinically significant or requires active intervention NOTE: \*Supplement allowed
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 2 weeks since prior tumor biopsy (4 weeks since prior surgical resection)
  • Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed at discretion of principal investigator
  • Prior hydroxyurea allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 1 week for metronomic-dosed chemotherapy \[e.g., daily etoposide hydrochloride or cyclophosphamide\]) and recovered
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 2 weeks since prior immunotherapy and recovered
  • More than 4 weeks since prior investigational drugs and recovered
  • No prior platelet-derived growth factor- or vascular endothelial growth factor-directed therapies
  • More than 2 weeks since prior hematopoietic colony-stimulating factor (e.g., filgrastim \[G-CSF\] or sargramostim \[Granulocyte-macrophage colony-stimulating factor (GM-CSF)\])
  • Prior epoetin alfa allowed
  • No concurrent warfarin

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00387933

    Start Date

    July 1 2005

    Last Update

    October 14 2015

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710