Full Text View
Tabular View
No Study Results Posted
Related Studies
Monoclonal Antibody Therapy in Treating Patients With Brain Metastases
This study has been completed.
Study NCT00002751   Information provided by Duke University
First Received: November 1, 1999   Last Updated: October 12, 2009   History of Changes

November 1, 1999
October 12, 2009
July 1989
 
 
 
Complete list of historical versions of study NCT00002751 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy in Treating Patients With Brain Metastases
PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES

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/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have brain metastases.

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to this treatment.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2, 131I-Me1-14 F(ab')2.

PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied.

Phase I, Phase II
Interventional
Treatment
Metastatic Cancer
Biological: monoclonal antibody Me1-14 F(ab')2
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
6
May 2004
 

DISEASE CHARACTERISTICS: Histologically confirmed neoplasm that is recurrent in the subarachnoid space Biopsy of recurrent lesion required if original diagnosis made more than 2 years prior to entry and CSF cytology negative Radiographic evidence of measurable lesion in the leptomeninges (by myelography, CT, or MRI) or cytologic evidence of malignancy in the CSF Any type of neoplasm eligible provided tumor cells (tissue or CSF preparation) bind significantly to intact monoclonal antibody Me1-14 IgG2a or to Me1-14 F(ab')2 Patency of subarachnoid pathways demonstrated by isotopic intraventricular flow

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.2 mg/dL Other: No allergy to iodine Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior antineoplastic chemotherapy unless unequivocal evidence of tumor progression No concurrent systemic chemotherapy Endocrine therapy: Corticosteroids allowed if at lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of disease progression Surgery: Not specified

Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002751
Darell Bigner, MD, Duke UMC
CDR0000064687, DUMC-1193-006R11, DUMC-1017-96-7R7, DUMC-1100-97-7R8, DUMC-1159-98-7R9, DUMC-1229-99-7R10, DUMC-657897, DUMC-997-95-7R6, NCI-V90-0052, NCI-H96-0010
Duke University
 
Study Chair: Darell D. Bigner, MD, PhD Duke University
Duke University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP