Working… Menu

Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003484
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : April 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Darell D. Bigner, MD, PhD, Duke University

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Neuroblastoma Drug: carmustine Drug: irinotecan hydrochloride Procedure: surgical procedure Radiation: iodine I 131 monoclonal antibody 81C6 Phase 1

Detailed Description:


  • Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy.
  • Determine objective therapeutic responses of these patients to this treatment.

OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6).

Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter.

Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I.

Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression.

Patients are followed initially at 4 weeks, then every 6 weeks for 1 year.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy
Study Start Date : September 1997
Actual Primary Completion Date : November 2003
Actual Study Completion Date : March 2010

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor
  • No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors
  • Candidate for surgical resection
  • Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required
  • Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6



  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 1.5 mg/dL
  • Alkaline phosphatase less than 1.5 times normal
  • Lactic dehydrogenase less than 1.5 times normal
  • SGOT less than 1.5 times normal


  • Creatinine less than 1.2 mg/dL


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No iodine allergies


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days


  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003484

Layout table for location information
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Darell D. Bigner, MD, PhD
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Darell D. Bigner, MD, PhD Duke University
Layout table for additonal information
Responsible Party: Darell D. Bigner, MD, PhD, Director, The Preston Robert Tisch Brain Tumor Center at Duke, Duke University Identifier: NCT00003484    
Other Study ID Numbers: Pro00008915
DUMC-1533-02-8R5ER ( Other Identifier: Duke University IRB )
DUMC-1533-01-8R4 ( Other Identifier: Duke University IRB )
DUMC-1373-97-9 ( Other Identifier: Duke University IRB )
DUMC-1408-98-9R1 ( Other Identifier: Duke University IRB )
DUMC-1533-00-8R3 ( Other Identifier: Duke University IRB )
DUMC-1570-99-9R2 ( Other Identifier: Duke University IRB )
DUMC-97107 ( Other Identifier: Duke University Cancer Protocol Committee )
5P0NS20023 ( Other Grant/Funding Number: National Cancer Institute )
NCI-G98-1472 ( Other Grant/Funding Number: National Cancer Institute )
CDR0000066522 ( Other Identifier: National Cancer Institute Record Identifier )
First Posted: April 30, 2003    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015
Keywords provided by Darell D. Bigner, MD, PhD, Duke University:
localized resectable neuroblastoma
recurrent adult brain tumor
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult glioblastoma
adult oligodendroglioma
adult anaplastic astrocytoma
adult mixed glioma
adult pineal parenchymal tumor
adult central nervous system germ cell tumor
adult grade III meningioma
adult pilocytic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents