Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors
surgical procedure
+ astatine At 211 monoclonal antibody 81C6
Maladies du cerveau+29
+ Maladies du système nerveux central
+ Néoplasmes Méningés
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors. Identify objective therapeutic responses of these patients to this treatment. OUTLINE: This is a dose escalation study. Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter. Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity. Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.
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.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.À partir de 18 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 newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor Measurable disease by MRI or CT scan Candidate for surgical resection Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL Alkaline phosphatase less than 1.5 times normal SGOT less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression Endocrine therapy: Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week Radiotherapy: At least 3 months since prior radiotherapy to site of measurable disease in the CNS Surgery: See Disease Characteristics
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
Duke Comprehensive Cancer Center
Durham, United StatesOuvrir Duke Comprehensive Cancer Center dans Google Maps