Know Cancer

or
forgot password

A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

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 CenterLebanon, New Hampshire  03756