RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive
tumor-killing substances to them without harming normal cells. This may be effective
treatment for primary or metastatic brain tumors.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody
therapy in treating patients with primary or metastatic brain tumors.
- 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
- 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
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
- 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
- 18 and over
- Karnofsky 50-100%
- Not specified
- Absolute neutrophil count greater than 1000/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin less than 1.5 mg/dL
- Alkaline phosphatase less than 1.5 times normal
- SGOT less than 1.5 times normal
- Creatinine less than 1.2 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression
- Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week
- At least 3 months since prior radiotherapy to site of measurable disease in the CNS
- See Disease Characteristics