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

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002752
• Other study ID #: Pro00004635
• Secondary ID: DUMC-2426-01-2R8
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 1999
• Last updated: July 15, 2014
• Start date: February 1993
• Est. completion date: March 2010

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• 3 and over

Performance status:

• Karnofsky 50-100%

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• AST less than 1.5 times normal

• Alkaline phosphatase less than 1.5 times normal

Renal:

• Creatinine less than 1.2 mg/dL

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression

Endocrine therapy:

• Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry

Radiotherapy:

• At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression

Surgery:

• See Disease Characteristics

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Nervous System Neoplasms

Intervention

Radiation:
• iodine I 131 monoclonal antibody 81C6

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States,