Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
conventional surgery
+ iodine I 131 monoclonal antibody TNT-1/B
Enfermedades del Cerebro+11
+ Enfermedades del Sistema Nervioso Central
+ Glioma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2000
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B. Determine the median survival time of these patients treated with this regimen. Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic, hematologic, and biochemical profiles in these patients. Confirm the maximum tolerated dose of this regimen in these patients. Optimize the drug delivery of this regimen in these patients. Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug. OUTLINE: This is a multicenter study. Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed. One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial response, minimal response, or stable disease repeat the above treatments during week 9. Patients with complete response, progressive disease, or unacceptable toxicity receive no additional treatment. Patients are followed every month until disease progression. All patients regardless of disease progression or retreatment are followed at 36 weeks. PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with recurrent anaplastic astrocytoma) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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 unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA) MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3 Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking At least 5 days since prior surgical debulking No planned resection of newly diagnosed GBM before or during study No bilateral noncontiguous gadolinium enhancing tumors No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip No more than 2 satellite lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 WBC at least 3,000/mm^3 Hepatic: Hepatitis B surface antigen negative Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Lactic dehydrogenase no greater than 3 times ULN Prothrombin time no greater than 1.5 times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No significant unstable cardiovascular disease No New York Heart Association class III/IV heart disease No evidence of myocardial infarction within the past 3 months Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception Human antichimeric antibody (HACA) titer no greater than 48 ng/mL No anatomical or physiological considerations that would preclude study participation No active autoimmune disease, active infection, or traumatic injury requiring treatment HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers Endocrine therapy: Not specified Radiotherapy: At least 8 weeks since prior external beam or gamma knife radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational treatment
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 4 ubicaciones
Carolina Neurosurgery and Spine Associates
Charlotte, United StatesAbrir Carolina Neurosurgery and Spine Associates en Google MapsTemple University
Philadelphia, United StatesMedical University of South Carolina
Charleston, United StatesHuntsman Cancer Institute
Salt Lake City, United States