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Status:

COMPLETED

Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Brain Tumor

Adult Giant Cell Glioblastoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

This phase I/II trial is studying the side effects and best dose of tandutinib and to see how well it works in treating patients with recurrent or progressive glioblastoma.Tandutinib may stop the grow...

Detailed Description

PRIMARY OBJECTIVES: I. Assess the ability of tandutinib to achieve a target tumor/plasma ratio ≥ 0.33 in patients with recurrent glioblastoma undergoing resection. (Feasibility study) II. Detect pote...

Eligibility Criteria

Inclusion

  • Criteria:
  • Histologically confirmed glioblastoma:
  • Progressive or recurrent disease after prior radiotherapy (with or without chemotherapy)
  • Patients with a previous low-grade glioma that progressed after prior radiotherapy (with or without chemotherapy) and are found to have glioblastoma by biopsy are eligible
  • Measurable disease, defined as contrast-enhancing progressive or recurrent glioblastoma by MRI or CT imaging within the past 2 weeks
  • Must be maintained on a stable corticosteroid regimen from the time of baseline scan to the start of study treatment
  • Feasibility study only:
  • Planning to undergo surgical resection or biopsy
  • Stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects allowed
  • Corticosteroids must be tapered to the lowest required steroid dose and patient must be maintained on a stable dose after surgery or biopsy
  • Karnofsky performance status 60-100%
  • Absolute neutrophil count \>= 1,500/mm\^3
  • Hemoglobin \>= 10 mg/dL
  • Bilirubin =\< 1.5 mg/dL
  • AST and ALT =\< 4 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
  • Mini Mental State Exam score \>= 15
  • Mean QTc =\< 500 msec (with Bazett's correction) by screening electrocardiogram
  • LVEF \>= 40%
  • No history of familial long QT syndrome
  • No myocardial infarction within the past 6 months
  • No severe uncontrolled ventricular arrhythmias
  • No uncontrolled angina
  • No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • No ongoing vomiting or nausea \>= grade 2
  • No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous alimentation
  • No active peptic ulcer disease
  • No other condition that would impair ability to swallow pills or absorb oral medications
  • No muscular dystrophy
  • No myasthenia gravis
  • No other known or suspected primary muscular or neuromuscular disease
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib (e.g., erlotinib hydrochloride, gefetinib, or doxazosin mesylate)
  • Patients who developed an acneiform/maculopustular rash while receiving either gefitinib or erlotinib hydrochloride are eligible unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome
  • No ongoing or active infections
  • No psychiatric illness or social situations that would preclude study compliance
  • No other serious infection or medical illness
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No other uncontrolled illness
  • No other malignancy within the past 5 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
  • Recovered from prior therapy
  • At least 3 months since prior radiotherapy
  • No prior surgical procedures affecting absorption
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent agent that would cause QTc prolongation
  • No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
  • At least 10 days since prior and no concurrent anticonvulsant drugs that induce hepatic metabolic enzymes (e.g., primidone, oxcarbazepine, phenytoin, carbamazepine, or phenobarbital)
  • No prior treatment with small molecule inhibitors of platelet-derived growth factor receptor (e.g., sunitinib malate, sorafenib, or imatinib mesylate)
  • Platelet count \>= 100,000/mm\^3
  • No New York Heart Association class III or IV heart failure
  • Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 60mL/min

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2013

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00379080

    Start Date

    January 1 2007

    End Date

    June 1 2013

    Last Update

    April 7 2017

    Active Locations (9)

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

    Page 1 of 3 (9 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, United States, 33612

    3

    Emory University

    Atlanta, Georgia, United States, 30322

    4

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287