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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00002752
First received: November 1, 1999
Last updated: July 15, 2014
Last verified: February 2013
  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
Metastatic Cancer
Radiation: iodine I 131 monoclonal antibody 81C6
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Study Start Date: February 1993
Study Completion Date: March 2010
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00002752     History of Changes
Other Study ID Numbers: Pro00004635, 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, CDR0000064688
Study First Received: November 1, 1999
Last Updated: July 15, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
childhood supratentorial ependymoma
recurrent childhood brain tumor
recurrent adult brain tumor
adult medulloblastoma
adult glioblastoma
tumors metastatic to brain
childhood high-grade cerebral astrocytoma
adult anaplastic astrocytoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
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

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014