PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of iodine-131-labeled
monoclonal antibody fragment ME1-14 F(ab')2 administered intracystically in patients with
recurrent or newly diagnosed primary or metastatic malignant melanoma or other brain tumors.
II. Identify any objective therapeutic responses to this treatment.
OUTLINE: All patients receive a fixed dose of monoclonal antibody fragment ME1-14 F(ab')2
via an intralesional catheter; cohorts of 3-6 patients receive escalating doses of isotope
conjugated to the antibody until the maximum tolerated dose is determined. Patients with
newly diagnosed disease at entry may receive additional therapy with external-beam
radiotherapy beginning 4 months after radioimmunotherapy (or sooner if disease progression
occurs). Patients with recurrent disease at entry are followed without further therapy for
at least 4 months after radioimmunotherapy; alternative therapy may be offered upon
progression. All patients are followed at 4, 8, 16, and 24 weeks after treatment, then every
12 weeks for 1 year.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
Primary Purpose: Treatment
Darell D. Bigner, MD, PhD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|