Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Phase 1

Completed

• Conditions: Metastatic Cancer; Brain and Central Nervous System Tumors

• Registration Number: NCT00002752
• Lead Sponsor: Duke University

Brief Summary

RATIONALE: Radiolabeled 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 study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.

Detailed Description

OBJECTIVES:

* Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.

* Determine the objective therapeutic response of these patients treated with this regimen.

OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no).

Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly.

Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.

Study Timeline

• Study Start: 1993-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-01
• Study First Submitted QC: 2003-07-07
• Study First Posted: 2003-07-08
• Study Completion: 2010-03
• Status Verified: 2013-02
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States