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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003461
First Posted: January 27, 2003
Last Update Posted: August 21, 2014
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University
  Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors Metastatic Cancer Neuroblastoma Procedure: surgical procedure Radiation: astatine At 211 monoclonal antibody 81C6 Phase 1 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors

Resource links provided by NLM:


Further study details as provided by Duke University:

Study Start Date: February 1998
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.
  • Identify objective therapeutic responses of these patients to this treatment.

OUTLINE: This is a dose escalation study.

Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.

Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.

Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor
  • Measurable disease by MRI or CT scan

    • Candidate for surgical resection
    • Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity
  • Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody
  • No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 1.2 mg/dL

Other:

  • Not pregnant or nursing
  • 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 progression

Endocrine therapy:

  • Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week

Radiotherapy:

  • At least 3 months since prior radiotherapy to site of measurable disease in the CNS

Surgery:

  • See Disease Characteristics
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003461


Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00003461     History of Changes
Other Study ID Numbers: 2237
DUMC-2237-01-12R4
DUMC-0013-00-1R2
DUMC-0036-99-1R1
DUMC-060-98-1
DUMC-2237-00-12R3
DUMC-98007
NCI-5P50NS20023
NCI-G98-1462
CDR0000066493
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: August 21, 2014
Last Verified: February 2013

Keywords provided by Duke University:
localized resectable neuroblastoma
recurrent neuroblastoma
recurrent adult brain tumor
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult glioblastoma
adult oligodendroglioma
tumors metastatic to brain
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
adult pineal gland astrocytoma

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