A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
liposomal vincristine sulfate
+ cryosurgery
+ laser surgery
Maladies oculaires+11
+ Néoplasmes de l'œil
+ Néoplasmes germinaux et embryonnaires
Étude thérapeutique
Résumé
Date de début de l'étude : 16 avril 2007
Date à laquelle le premier participant a commencé l'étude.PRIMARY OBJECTIVES: I. Determine the event-free survival at 12 months of pediatric patients' eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine, carboplatin, and etoposide, subtenon carboplatin, and local ophthalmic therapy. (Event defined for each eye individually as needed for nonprotocol therapy including nonprotocol chemotherapy, enucleation or any external-beam radiation) SECONDARY OBJECTIVES: I. Determine the event-free survival at 12 months of pediatric patients' eyes with group C retinoblastoma treated with systemic chemotherapy comprising carboplatin, etoposide, vincristine, subtenon carboplatin, and local ophthalmic therapy. II. Determine the acute and long-term toxic effects of these regimens in these patients, including visual outcome and incidence of secondary malignancies. III. Determine the patterns of failure in patients treated with these regimens, in terms of vitreous vs retinal vs both as sites of recurrence. IV. Determine predictors of failure including findings at the on study examination under anesthesia and response status after six courses of chemotherapy. V. Determine the percentage of group C and D eyes separately that can be preserved without enucleation after failing protocol therapy. OUTLINE: This is a multicenter study. Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or cryotherapy on day 1. Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age, every 6 months until 5 years of age, and then annually for up to 10 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.30 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 17 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
Inclusion Criteria: * Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following: * Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding * Subretinal fluid, without prior or concurrent seeding, involving ≤ one quarter of the retina * Local fine vitreous seeding may be present close to discrete tumor * Local subretinal seeding \< 3 mm from tumor * Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules * Prior enucleation of 1 eye allowed provided the remaining eye is group C or D * No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry * Evidence of choroidal and/or optic nerve invasion past the lumina cribrosa is allowed * No extraocular retinoblastoma clinically or by MRI of brain and orbits with and without gadolinium or CT scan with and without contrast of brain and orbits * No evidence of systemic metastases by bone marrow, lumbar puncture, bone scan, and/or any other additional test * Performance status - Karnofsky 50-100% (over 16 years of age) * Performance status - Lansky 50-100% (16 and under) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * AST and ALT \< 2.5 times ULN for age * Creatinine adjusted according to age as follows: * No greater than 0.4 mg/dL (≤ 5 months) * No greater than 0.5 mg/dL (6 months -11 months) * No greater than 0.6 mg/dL (1 year-23 months) * No greater than 0.8 mg/dL (2 years-5 years) * No greater than 1.0 mg/dL (6 years-9 years) * No greater than 1.2 mg/dL (10 years-12 years) * No greater than 1.4 mg/dL (13 years and over \[female\]) * No greater than 1.5 mg/dL (13 years to 15 years \[male\]) * No greater than 1.7 mg/dL (16 years and over \[male\]) * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73m\^2 * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test in postmenarchal females * No prior chemotherapy * No other concurrent chemotherapy * No prior radiotherapy * No other concurrent radiotherapy
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 11 sites
Southern California Permanente Medical Group
Downey, United StatesChildren's Hospital Los Angeles
Los Angeles, United StatesYale University
New Haven, United States