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| 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 |
| Estimated Enrollment: | 6 |
| Study Start Date: | July 1989 |
| Study Completion Date: | May 2004 |
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 |
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| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Darell D. Bigner, MD, PhD | Duke University |
More Information
| 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 |
|
leptomeningeal metastases |
|
Antibodies, Monoclonal Antibodies Neoplasms Neoplastic Processes Pathologic Processes |
Immunologic Factors Physiological Effects of Drugs Neoplasm Metastasis Pharmacologic Actions Immunoglobulins |