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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


Phase 1
1 Year
21 Years
Not Enrolling
Both
Malignant Brain Tumor, Brain Stem Glioma,

Thank you

Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy

Outcome Time Frame:

End of recruitment

Safety Issue:

Yes

Principal Investigator

Vassal Gilles, Pr.

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSET 1120

NCT ID:

NCT00418327

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Malignant Brain Tumor
  • Brain Stem Glioma,
  • Tarceva
  • refractory and relapsed malignant brain tumors
  • newly diagnosed brain stem glioma
  • Brain Neoplasms
  • Glioma

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