Trial record 1 of 1 for:
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
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
This study has been completed.
Sponsor:
Institut Gustave Roussy
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00418327
First received: January 3, 2007
Last updated: August 6, 2009
Last verified: August 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Malignant Brain Tumor Brain Stem Glioma, |
Drug: Tarceva (Erlotinib Hydrochloride) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Institut Gustave Roussy:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To define Dose Limiting Toxicities (DLTs) [ Time Frame: 3 cycles-6 cycles ] [ Designated as safety issue: Yes ]
- To define the safety profile [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate efficacy [ Time Frame: Cycles 2,4,6, end of treatment ] [ Designated as safety issue: No ]
- To evaluate expression and mutations of EGFR with efficacy [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2005 |
Intervention Details:
Detailed Description:
-
Drug: Tarceva (Erlotinib Hydrochloride)
tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations More Information
No publications provided by Institut Gustave Roussy
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Geoerger Birgit/Coordinating Physician, Institut Gustave Roussy |
| ClinicalTrials.gov Identifier: | NCT00418327 History of Changes |
| Other Study ID Numbers: | CSET 1120 |
| Study First Received: | January 3, 2007 |
| Last Updated: | August 6, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Gustave Roussy:
|
Tarceva refractory and relapsed malignant brain tumors newly diagnosed brain stem glioma |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Erlotinib Central Nervous System Diseases Nervous System Diseases Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013