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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

History of Changes

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Biological: bispecific antibody MDX447 Biological: lymphokine-activated killer cells Procedure: conventional surgery	Phase 1


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:


Study Start Date:	March 1997
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005813

Locations


United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Camilo E Fadul, MD	Dartmouth-Hitchcock Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00005813 History of Changes
Other Study ID Numbers:	D9705, P30CA023108, NCI-G00-1783
Study First Received:	June 2, 2000
Last Updated:	October 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:


adult glioblastoma adult giant cell glioblastoma adult gliosarcoma

Additional relevant MeSH terms:


Central Nervous System Neoplasms Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial	Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Antibodies, Bispecific Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015

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