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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00002752

Collaborator

(none)

Location

204.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Metastatic Cancer	Radiation: iodine I 131 monoclonal antibody 81C6	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS

Study Start Date :

Feb 1, 1993

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Mar 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically proven primary or metastatic malignant supratentorial anaplastic glioma
Newly diagnosed or recurrent
No diffusely infiltrating or multifocal tumor
No tumor with subependymal spread
Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study
Measurable lesion on enhanced CT scan or MRI
No measurable enhancing lesion greater than 1.0 cm beyond cavity margin
Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody