NCT00005813

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1997

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 20, 2003

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

5.8 years

First QC Date

June 2, 2000

Last Update Submit

October 26, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

bispecific antibody MDX447BIOLOGICAL
lymphokine-activated killer cellsBIOLOGICAL
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Camilo E Fadul, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

May 20, 2003

Study Start

March 1, 1997

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

US(1)