A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Camilo E Fadul, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dartmouth-Hitchcock Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
D9705
NCT ID:
NCT00005813
Start Date:
March 1997
Completion Date:
January 2003
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
