NCT00003478

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

9.8 years

First QC Date

November 1, 1999

Last Update Submit

February 15, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult brain stem gliomaadult medulloblastomaadult glioblastomaadult anaplastic astrocytomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult ependymoblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

conventional surgeryPROCEDURE
iodine I 131 monoclonal antibody 81C6RADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven newly diagnosed or recurrent primary intracranial WHO grade III or IV glioma * Reactivity of tumor cells with 81C6 demonstrated by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody * Radiographic evidence of a single lesion by MRI or CT scan * No greater than 2 to 5 cm * No cerebral herniation syndrome * Midline brain shift less than 0.5 cm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 1.5 times normal * SGOT less than 1.5 times normal Renal: * Creatinine less than 2.0 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No allergies to iodine or local anesthetics PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent autologous bone marrow transplant Chemotherapy: * No more than 1 prior conventional or phase II chemotherapy regimen * No prior phase I chemotherapy regimens * At least 4 weeks since prior chemotherapy * No concurrent systemic chemotherapy Endocrine therapy: * Corticosteroids allowed but must be on stable dose for at least 1 week Radiotherapy: * At least 3 months since radiotherapy to site of measurable disease in the nervous system, unless evidence of progression 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 NeoplasmsMedulloblastomaGlioblastomaAstrocytomaEpendymomaOligodendrogliomaGliomaNeuroectodermal Tumors, PrimitiveGliosarcoma

Interventions

Radiotherapy

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Darell D. Bigner, MD, PhD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1997

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

US(1)