Trial Information

Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy

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.