LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00003020
First received: November 1, 1999
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients who have leptomeningeal metastases metastases.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: LMB-7 immunotoxin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Protocol for a Phase I Study of Intrathecal LMB-7 (Single-Chain Immunotoxin Constructed From Monoclonal Antibody B3-Pseudomonas Exotoxin PE 38) [IND 5863, NSC 658931] in the Treatment of Patients With Leptomeningeal Neoplasms

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 24
Study Start Date: September 1997
Study Completion Date: September 2000
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the toxicity of intrathecal LMB-7 immunotoxin in patients with leptomeningeal metastases. II. Identify objective therapeutic responses in this group of patients.

OUTLINE: This is a dose escalation study. Patients receive LMB-7 intrathecally on days 1, 3, and 5. Treatment may be repeated every 4 weeks if the patient does not demonstrate HAMA neutralizing antibodies to PE-38 in CSF, has stable or responding disease, and has not experienced greater than grade II toxicity. Three to six patients are entered at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience grade 3 or worse toxicity or a neuroradiology toxicity score of 10 or greater.

PROJECTED ACCRUAL: Approximately 15 to 24 patients will be accrued over one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven primary intracranial or extraneural neoplasm with leptomeningeal metastases At least 30% of malignant cells in the cerebrospinal fluid, primary tumor, or metastatic tumor must react with the B3 mouse monoclonal antibody

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: ANC greater than 1000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.2 mg/dL Pulmonary: DLCO at least 60 Other: No neutralizing antibodies to Pseudomonas exotoxin Not pregnant or nursing Not allergic to penicillin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy within past 4 weeks (6 weeks for nitrosoureas) unless there is evidence of disease progression in CNS No concurrent chemotherapy Endocrine therapy: Patients receiving corticosteroids must be on stable dose for 10 days prior to entry Radiotherapy: No radiotherapy to disease site within past 3 months unless there is evidence of disease progression in CNS No concurrent radiotherapy Surgery: Not specified

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003020

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00003020     History of Changes
Other Study ID Numbers: CDR0000065605, DUMC-0511-99-3R2, DUMC-000428-00-3R3, DUMC-424-98-3R1, DUMC-460-97-3, NCI-T96-0012
Study First Received: November 1, 1999
Last Updated: February 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
leptomeningeal metastases

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Antibodies, Monoclonal
Immunotoxins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014