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
Enfermedades del Cerebro+23
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias Meningeas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1998
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Centros del Estudio
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Duke Comprehensive Cancer Center
Durham, United StatesAbrir Duke Comprehensive Cancer Center en Google Maps