Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors

Metastatic Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors.

Clinical Trial Description

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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis
• Nervous System Neoplasms

• NCT number: NCT00002754
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 1
• Start date: February 1993
• Completion date: April 2001