Full Text View
Tabular View
No Study Results Posted
Related Studies
Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Study NCT00005813   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes

June 2, 2000
February 6, 2009
March 1997
 
 
 
Complete list of historical versions of study NCT00005813 on ClinicalTrials.gov Archive Site
 
 
 
Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme

RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.

OBJECTIVES:

  • Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
  • Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.

Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Biological: bispecific antibody MDX447
  • Biological: lymphokine-activated killer cells
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces

    • No astrocytoma, anaplastic astrocytoma, or oligodendroglioma
    • No infratentorial or multifocal tumor
  • Recurrence or progression following at least one prior therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 2.0 times ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other medical or psychiatric illness that would preclude study
  • No other concurrent malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)

Endocrine therapy:

  • Concurrent steroid therapy allowed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005813
 
CDR0000067815, DMS-9705, NCI-G00-1783
Norris Cotton Cancer Center
National Cancer Institute (NCI)
Study Chair: Camilo E. Fadul, MD Norris Cotton Cancer Center
National Cancer Institute (NCI)
April 2003

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