Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
  PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.

Detailed description: OBJECTIVES:
  -  Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.
  -  Determine the objective therapeutic response of these patients treated with this regimen.
  OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no).
  Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly.
  Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
  Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter.
  PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven primary or metastatic malignant supratentorial anaplastic glioma
  -  Newly diagnosed or recurrent
  -  No diffusely infiltrating or multifocal tumor
  -  No tumor with subependymal spread
  -  Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study
  -  Measurable lesion on enhanced CT scan or MRI
  -  No measurable enhancing lesion greater than 1.0 cm beyond cavity margin
  -  Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody
  PATIENT CHARACTERISTICS:
  Age:
  -  3 and over
  Performance status:
  -  Karnofsky 50-100%
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Bilirubin less than 1.5 mg/dL
  -  AST less than 1.5 times normal
  -  Alkaline phosphatase less than 1.5 times normal
  Renal:
  -  Creatinine less than 1.2 mg/dL
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  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 tumor progression
  Endocrine therapy:
  -  Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry
  Radiotherapy:
  -  At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant