Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Darell D. Bigner, Duke University Medical Center Identifier:
First received: November 1, 1999
Last updated: December 12, 2012
Last verified: December 2012

November 1, 1999
December 12, 2012
September 1997
November 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003484 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
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

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.


  • 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.

Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • Drug: carmustine
  • Drug: irinotecan hydrochloride
  • Procedure: surgical procedure
  • Radiation: iodine I 131 monoclonal antibody 81C6
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
November 2003   (final data collection date for primary outcome measure)


  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Pro00008915, DUMC-1533-02-8R5ER, DUMC-1533-01-8R4, DUMC-1373-97-9, DUMC-1408-98-9R1, DUMC-1533-00-8R3, DUMC-1570-99-9R2, DUMC-97107, 5P0NS20023, NCI-G98-1472, CDR0000066522
Not Provided
Darell D. Bigner, Duke University Medical Center
Darell D. Bigner
National Cancer Institute (NCI)
Study Chair: Darell D. Bigner, MD, PhD Duke University
Duke University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP