NCT00003461

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 1998

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

February 1, 1998

Completed
1.7 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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

August 21, 2014

Status Verified

February 1, 2013

Enrollment Period

7 years

First QC Date

November 1, 1999

Last Update Submit

August 20, 2014

Conditions

Brain and Central Nervous System TumorsMetastatic CancerNeuroblastoma

Keywords

localized resectable neuroblastomarecurrent neuroblastomarecurrent adult brain tumoradult craniopharyngiomaadult medulloblastomaadult meningiomaadult glioblastomaadult oligodendrogliomatumors metastatic to brainadult anaplastic astrocytomaadult mixed gliomaadult pineal parenchymal tumoradult central nervous system germ cell tumoradult grade III meningiomaadult pilocytic astrocytomaadult giant cell glioblastomaadult gliosarcomaadult pineal gland astrocytoma

Interventions

surgical procedurePROCEDURE
astatine At 211 monoclonal antibody 81C6RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor * Measurable disease by MRI or CT scan * Candidate for surgical resection * Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity * Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody * No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1000/mm\^3 * Platelet count greater than 100,000/mm\^3 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 1.2 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression Endocrine therapy: * Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week Radiotherapy: * At least 3 months since prior radiotherapy to site of measurable disease in the CNS Surgery: * See Disease Characteristics

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 NeoplasmsNeoplasm MetastasisNeuroblastomaBrain NeoplasmsCraniopharyngiomaMedulloblastomaMeningiomaGlioblastomaOligodendrogliomaAstrocytomaGliomaPinealomaGliosarcoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System DiseasesNeoplasms, Vascular TissueMeningeal Neoplasms

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

January 27, 2003

Study Start

February 1, 1998

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

August 21, 2014

Record last verified: 2013-02

Locations

US(1)