A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
carboplatin
+ temozolomide
+ vincristine sulfate
Maladies du cerveau+15
+ Néoplasmes cérébraux
+ Maladies du système nerveux central
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas. Secondary * Determine response rate in patients treated with this regimen. * Determine 3-year progression-free survival and overall survival of patients treated with this regimen. * Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen. OUTLINE: This is a pilot study. * Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. * Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.66 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 10 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following: * WHO grade I or II astrocytoma * Grade I or II oligodendrogliomas * Mixed oligodendrogliomas * Gangliogliomas * Measurable disease * Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed * Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome * Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms) * No diffuse brain stem tumors * No type 1 neurofibromatosis PATIENT CHARACTERISTICS: Age * 10 and under Performance status * ECOG 0-2 * Lansky 50-100% Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 8.0 gm/dL * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN Renal * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR * Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunomodulating agents Chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Prior corticosteroids allowed * No concurrent corticosteroids except for the treatment of increased intracranial pressure Radiotherapy * Not specified Surgery * See Disease Characteristics * Prior surgery allowed Other * No other prior therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site