Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
verteporfin
+ conventional surgery
Maladies du cerveau+38
+ Maladies du système nerveux central
+ Néoplasmes des Ventricules Cérébraux
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1994
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy. Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors). Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection. Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD. Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 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.24 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.De 3 à 70 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: Diagnosis of supratentorial or infratentorial brain tumor Localized, non-disseminated Primary tumor or solitary metastasis Recurrent or progressive Unresectable Negative CSF Must have failed standard therapy including radiotherapy Measurable disease as evidenced by CT scan or MRI Single or multiple masses accessible to light administration PATIENT CHARACTERISTICS: Age: 3 to 70 Performance status: Not specified Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 May transfuse platelets Hepatic: PT and PTT normal Renal: Not specified Other: Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior brachytherapy Surgery: See Disease Characteristics Other: No other concurrent antitumor therapy
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 2 sites
Medical College of Wisconsin Cancer Center
Milwaukee, United StatesOuvrir Medical College of Wisconsin Cancer Center dans Google MapsMidwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, United States