ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379080
  Purpose

RATIONALE: Tandutinib 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.

PURPOSE: 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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: tandutinib
Procedure: biopsy
Procedure: conventional surgery
Procedure: pharmacological study
Phase I
Phase II

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   1-Piperazinecarboxamide, 4-(6-methoxy-7-(3-(1-piperidinyl)propoxy)-4-quinazolinyl)-N-(4-(1-methylethoxy)phenyl)-   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label
Official Title:   A Feasibility Assessment and a Phase I/II Trial of MLN518 for Treatment of Patients With Recurrent Glioblastoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ability of tandutinib to achieve a target tumor/plasma ratio ≥ 0.33 (feasibility study) [ Designated as safety issue: No ]
  • Maximum tolerated dose of tandutinib (phase I) [ Designated as safety issue: Yes ]
  • Safety and efficacy of tandutinib (phase I) [ Designated as safety issue: Yes ]
  • Tumor response (complete response and partial response) rate (phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (phase II) [ Designated as safety issue: No ]
  • Six-month progression-free (complete or partial response or stable disease) survival rate (phase II) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile [ Designated as safety issue: No ]
  • Protein expression patterns that distinguish patients who respond to therapy from those who do not (phase II) [ Designated as safety issue: No ]

Estimated Enrollment:   85
Study Start Date:   January 2007
Estimated Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 mg/dL
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60mL/min
  • 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 New York Heart Association class III or IV heart failure
  • 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
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 3 months since prior radiotherapy
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • 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)
  • 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])
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379080

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham     Recruiting
      Birmingham, Alabama, United States, 35294
      Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer     205-934-0309        
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida     Recruiting
      Tampa, Florida, United States, 33612-9497
      Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
United States, Georgia
Winship Cancer Institute of Emory University     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: Jeffrey J. Olson, MD     404-778-5770        
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins     Recruiting
      Baltimore, Maryland, United States, 21231-2410
      Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
      Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital     Recruiting
      Detroit, Michigan, United States, 48202
      Contact: Tom Mikkelsen, MD     313-916-8641     nstom@neuro.hfh.edu    
United States, North Carolina
Wake Forest University Comprehensive Cancer Center     Recruiting
      Winston-Salem, North Carolina, United States, 27157-1096
      Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
Cleveland Clinic Taussig Cancer Center     Recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania     Recruiting
      Philadelphia, Pennsylvania, United States, 19104-4283
      Contact: Clinical Trials Office - Abramson Cancer Center of the Univers     800-474-9892        

Sponsors and Collaborators

Investigators
Study Chair:     Tracy Batchelor, MD, MPH     Massachusetts General Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000495253, NABTT-0504
First Received:   September 19, 2006
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00379080
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adult giant cell glioblastoma  
adult glioblastoma  
adult gliosarcoma  
recurrent adult brain tumor  

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Recurrence
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers