Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors

Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.
  PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.

Detailed description: OBJECTIVES:
  -  Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy.
  -  Determine objective therapeutic responses of these patients to this treatment.
  OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6).
  Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter.
  Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
  After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I.
  Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression.
  Patients are followed initially at 4 weeks, then every 6 weeks for 1 year.
  PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor
  -  No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors
  -  Candidate for surgical resection
  -  Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required
  -  Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6
  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
  -  Lactic dehydrogenase 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
  -  No iodine allergies
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days
  Radiotherapy:
  -  See Disease Characteristics
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant