NCT00002753

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 1991

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

November 1, 1991

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

July 29, 2004

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

9.4 years

First QC Date

November 1, 1999

Last Update Submit

February 15, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood supratentorial ependymomarecurrent childhood brain tumorrecurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult ependymoblastomarecurrent childhood cerebral astrocytomarecurrent childhood ependymomaadult giant cell glioblastomaadult gliosarcoma

Interventions

iodine I 131 monoclonal antibody 81C6RADIATION

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic glioma with a recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Negative pregnancy test Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: See Disease Characteristics 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)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaEpendymomaOligodendrogliomaGliomaNeuroectodermal Tumors, PrimitiveFamilial ependymomaGliosarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Darell D. Bigner, MD, PhD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 29, 2004

Study Start

November 1, 1991

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)