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Monoclonal Antibody Therapy in Treating Patients With Brain Metastases
This study has been completed.
First Received: November 1, 1999   Last Updated: October 12, 2009   History of Changes
Sponsor: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00002751
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Biological: monoclonal antibody Me1-14 F(ab')2
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 6
Study Start Date: July 1989
Study Completion Date: May 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002751

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Darell D. Bigner, MD, PhD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke UMC ( Darell Bigner, MD )
Study ID Numbers: 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
Study First Received: November 1, 1999
Last Updated: October 12, 2009
ClinicalTrials.gov Identifier: NCT00002751     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Duke University:
leptomeningeal metastases

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antibodies
Neoplasms
Neoplastic Processes
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Neoplasm Metastasis
Pharmacologic Actions
Immunoglobulins

ClinicalTrials.gov processed this record on November 20, 2009