Trial Information

Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors

OBJECTIVES:

- Determine which one of two delivery techniques (bolus injection versus microinfusion)
provides the greater distribution volume of iodine I 131 antitenascin monoclonal
antibody 81C6 (I 131 MAb 81C6) administered intratumorally in patients with newly
diagnosed or recurrent malignant primary brain tumors.

- Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in
these patients.

- Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients.

OUTLINE: This is a randomized, dose-escalation study.

Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131
MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by
the other technique 3 days later. Each patient then receives a therapeutic dose by the most
efficient method. Both methods are delivered via a stereotactically-placed intralesional
catheter.

- Arm I: Bolus injection method

- Arm II: Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses
of I 131 MAb 81C6, with dose escalation occurring separately for each arm. After 10
patients are enrolled and the best method of administration is determined, all
subsequent patients receive I 131 MAb 81C6 by that method, and the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more the 2 of 6
patients experience dose-limiting toxicity.

Patients with newly diagnosed tumors for which no effective conventional therapy exists,
such as malignant glial tumors, are treated with external beam radiotherapy within 4 months
after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy
unless tumor progresses.

Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year.

PROJECTED ACCRUAL: At least 10 patients will be accrued for this study within 1 year.