Phase II trial of intravenous lobradimil and carboplatin in childhood brain tumors: a report from the Children's Oncology Group.
Cancer Chemother Pharmacol
; 58(3): 343-7, 2006 Sep.
Article
en En
| MEDLINE
| ID: mdl-16408203
ABSTRACT
BACKGROUND:
[corrected] Lobradimil is a synthetic bradykinin analog that rapidly and transiently increases the permeability of the blood-brain barrier (BBB). The combination of lobradimil and carboplatin was studied in pediatric patients with primary brain tumors in a phase II trial, the primary endpoints of which were to estimate the response rate and time to disease progression. PATIENTS ANDMETHODS:
Patients were stratified by histology into five cohorts brainstem glioma, high-grade glioma, low-grade glioma, medullobastoma/primitive neuroectodermal tumor (PNET), and ependymoma. Patients received carboplatin adaptively dosed to achieve a target AUC of 3.5 mg min/ml per day (7 mg.min/ml/cycle) intravenously over 15 min on 2 consecutive days and lobradimil 600 ng/kg ideal body weight/day on 2 consecutive days each 28 day cycle.RESULTS:
Forty-one patients, age 2-19 years, were enrolled; 38 patients, including 1 patient ultimately determined to have atypical neurocytoma, were evaluable for response. No objective responses were observed in the brainstem glioma (n=12) and high-grade glioma (n = 9) cohorts, although two patients with high-grade glioma had prolonged disease stabilization (>6 months). The study was closed for commercial reasons prior to achieving the accrual goals for the ependymoma (n = 8), medulloblastoma/PNET (n = 6) and low-grade glioma (n = 2) cohorts, although responses were observed in 1 patient with PNET and 2 patients with ependymoma.CONCLUSION:
The combination of lobradimil and carboplatin was inactive in childhood high-grade gliomas and brainstem gliomas.
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Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Encefálicas
/
Barrera Hematoencefálica
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Protocolos de Quimioterapia Combinada Antineoplásica
Tipo de estudio:
Etiology_studies
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Incidence_studies
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Observational_studies
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Risk_factors_studies
Límite:
Adolescent
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Adult
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Child
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Child, preschool
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Humans
Idioma:
En
Revista:
Cancer Chemother Pharmacol
Año:
2006
Tipo del documento:
Article
País de afiliación:
Estados Unidos