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

This study has been completed.

Sponsored by: Duke University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002752
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: iodine I 131 monoclonal antibody 81C6
Phase I
Phase II

MedlinePlus related topics:   Brain Cancer    Cancer    Childhood Brain Tumors   

ChemIDplus related topics:   Iodine    Cadexomer iodine    Sodium iodide I 131   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 1993

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.

  Eligibility
Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002752

Locations
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators
Duke University

Investigators
Study Chair:     Darell D. Bigner, MD, PhD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064688, DUMC-2426-01-2R8, DUMC-000223-00-2R7, DUMC-0328-99-2R6, DUMC-221-96-2R3, DUMC-307-97-2R4, DUMC-307-98-2R5, NCI-H96-0009
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002752
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood supratentorial ependymoma  
recurrent childhood brain tumor  
recurrent adult brain tumor  
adult medulloblastoma  
adult glioblastoma  
adult tumors metastatic to brain  
childhood high-grade cerebral astrocytoma  
adult anaplastic astrocytoma  
adult myxopapillary ependymoma  
adult anaplastic ependymoma  
adult anaplastic oligodendroglioma  
mixed gliomas  
adult pilocytic astrocytoma
adult subependymoma
adult ependymoblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
newly diagnosed childhood ependymoma
recurrent childhood ependymoma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Neuroectodermal Tumors, Primitive
Astrocytoma
Central Nervous System Neoplasms
Ependymoma
Recurrence
Antibodies, Monoclonal
Brain Neoplasms
Neuroectodermal Tumors
Antibodies
Medulloblastoma
Iodine
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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