Clinical Trial · NCT00002752

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Overview

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.

Sponsor

Duke University

Phase

Phase 1/2

Contacts

Darell D. Bigner, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00002752

Eligibility

Inclusion

Karnofsky 50-100%Hematopoietic:
At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progressionSurgery:
Negative pregnancy test
Newly diagnosed or recurrent
Fertile patients must use effective contraceptionBiologic therapy:
Measurable lesion on enhanced CT scan or MRI
At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progressionEndocrine therapy:
3 and overPerformance status:
Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entryRadiotherapy:
Creatinine less than 1.2 mg/dLOther:
AST less than 1.5 times normal
Absolute neutrophil count greater than 1,000/mm\^3
Platelet count greater than 100,000/mm\^3Hepatic:
Bilirubin less than 1.5 mg/dL
Alkaline phosphatase less than 1.5 times normalRenal:

Exclusion

No tumor with subependymal spread
Not specifiedChemotherapy:
Not pregnant
No diffusely infiltrating or multifocal tumor
No measurable enhancing lesion greater than 1.0 cm beyond cavity margin