Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00005813
First received: June 2, 2000
Last updated: October 26, 2011
Last verified: October 2011

June 2, 2000
October 26, 2011
March 1997
January 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005813 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Biological: bispecific antibody MDX447
  • Biological: lymphokine-activated killer cells
  • Procedure: conventional surgery
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
January 2003
January 2003   (final data collection date for primary outcome measure)

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
D9705, P30CA023108, NCI-G00-1783
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Principal Investigator: Camilo E Fadul, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
October 2011

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