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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00003461
First received: November 1, 1999
Last updated: February 15, 2013
Last verified: February 2013
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00003461

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: NCT00003461     History of Changes
Other Study ID Numbers: 2237 (CDR0000066493), 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
Study First Received: November 1, 1999
Last Updated: February 15, 2013
Health Authority: United States: Federal Government
United States: Instituational Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014