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Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418327
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : August 7, 2009
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Condition or disease Intervention/treatment Phase
Malignant Brain Tumor Brain Stem Glioma, Drug: Tarceva (Erlotinib Hydrochloride) Phase 1

Detailed Description:
Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is dismal; median survival of these children does not exceed 9 months. Radiation therapy may result in early and transient amelioration of symptoms, but have not contributed to increase or prolong survival. Moreover, chemotherapy has not increased this outcome to date.Prados et al. reported encouraging results from a phase I study of TarcevaTM/OSI-774 alone or with temozolomide (TMZ) in patients with malignant gliomas. Of 25 evaluated patients, 6 experienced PR: 4 GBM (glioblastoma multiforme) and 1 grade 3 astrocytoma treated with TarcevaTM alone, 1 GBM treated with TarcevaTM/TMZ; 2 had minor responses, and 3 stable diseases. These results in malignant glioma and the lack of efficacy in brain stem glioma with current treatment suggests the evaluation of this new therapeutic agent in children with relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with radiation therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Intervention Details:
  • Drug: Tarceva (Erlotinib Hydrochloride)
    tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily

Primary Outcome Measures :
  1. To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy [ Time Frame: End of recruitment ]

Secondary Outcome Measures :
  1. To define Dose Limiting Toxicities (DLTs) [ Time Frame: 3 cycles-6 cycles ]
  2. To define the safety profile [ Time Frame: End of treatment ]
  3. To characterize the pharmacokinetic behavior of TarcevaTM in children with brain tumors as a single agent and in combination with radiation therapy [ Time Frame: Cycles 1,2,3,4,5,6 ]
  4. To evaluate efficacy [ Time Frame: Cycles 2,4,6, end of treatment ]
  5. To evaluate expression and mutations of EGFR with efficacy [ Time Frame: End of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant brain tumor
  • Disease must be considered refractory to first line or relapsing after conventional therapy and for which no effective conventional treatment exists.·
  • Newly diagnosed, histologically proven brain stem glioma, except pilocytic astrocytomas.
  • Age: 1 to ≤ 21 years of age at study entry
  • Life expectancy: at least 8 weeks
  • ECOG Performance status ≤ 1 or Lansky-Play Scale>= 70%, and including children with motor paresis due to disease
  • Measurable or evaluable disease
  • No other serious concomitant illness
  • No organ toxicity > grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease

Exclusion Criteria:

  • Patients with spontaneous intratumoral hemorrhage will not be included in the study, in exception of small post-biopsy hemorrhage due to biopsy procedure
  • Pregnant and breast feeding woman
  • Uncontrolled intercurrent illness or active infection
  • Chemotherapy within 4 weeks prior to study medication (within 6 weeks, if the regimen contained a nitrosourea)
  • Radiation therapy within 6 weeks prior to study medication
  • Any clinical or non-clinical evidence of pulmonary dysfunction or pre-existing lung disease
  • Severe cardiac pathology; history of myocardial infarction within the year prior to inclusion
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
  • Treatment with Coumarin (warfarin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418327

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Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Study Chair: Vassal Gilles, Pr. Gustave Roussy, Cancer Campus, Grand Paris

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Geoerger Birgit/Coordinating Physician, Institut Gustave Roussy Identifier: NCT00418327    
Other Study ID Numbers: CSET 1120
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009
Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
refractory and relapsed malignant brain tumors
newly diagnosed brain stem glioma
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action