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

November 1, 1999
July 15, 2014
February 1993
January 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002752 on ClinicalTrials.gov Archive Site
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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
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

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
Radiation: iodine I 131 monoclonal antibody 81C6
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2010
January 2003   (final data collection date for primary outcome measure)

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
Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002752
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
Not Provided
Duke University
Duke University
Not Provided
Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
Duke University
February 2013

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