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 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: August 20, 2014
Last verified: February 2013

November 1, 1999
August 20, 2014
February 1998
February 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003461 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
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

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Neuroblastoma
  • Procedure: surgical procedure
  • Radiation: astatine At 211 monoclonal antibody 81C6
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003461
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
Not Provided
Duke University
Duke University
National Cancer Institute (NCI)
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