Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
Collecte de données
Astrocytome+29
+ Maladies du cerveau
+ Néoplasmes cérébraux
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2002
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors. * Estimate the maximum tolerated dose of this drug in these patients. * Describe the pharmacokinetics of this drug with and without dexamethasone in these patients. * Investigate the efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD. Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
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.53 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 21 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 recurrent or progressive (refractory) brain tumors * Histologic confirmation waived for brainstem gliomas * Bone marrow involvement allowed if transfusion independent PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * Lansky 60-100% OR * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * See Disease Characteristics * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin no greater than upper limit of normal * SGPT and SGOT less than 2.5 times normal * Albumin greater than 3 g/dL * PT/PTT no greater than 120% upper limit of normal * No overt hepatic disease Renal: * Creatinine no greater than 1.5 times normal OR * Glomerular filtration rate greater than 70 mL/min * No overt renal disease Cardiovascular: * No overt cardiac disease Pulmonary: * No overt pulmonary disease Other: * Neurologic deficits allowed if stable for at least 1 week prior to study * More than 3rd percentile weight for height * Able to swallow pills * No uncontrolled infection * No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 10 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 6 months since prior bone marrow transplantation * More than 1 week since prior growth factors Chemotherapy: * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study * Concurrent oral contraceptives or other hormonal contraceptive methods allowed Radiotherapy: * More than 6 weeks since prior substantial bone marrow radiotherapy * More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation * More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites Surgery: * Not specified Other: * No concurrent enzyme-inducing anticonvulsant drugs * No other concurrent anticancer or experimental drug therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs 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 9 sites
UCSF Comprehensive Cancer Center
San Francisco, United StatesOuvrir UCSF Comprehensive Cancer Center dans Google MapsChildren's National Medical Center
Washington D.C., United StatesDana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, United StatesDuke Comprehensive Cancer Center
Durham, United States