LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases

Brain and Central Nervous System Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003020
• Other study ID #: CDR0000065605
• Secondary ID: DUMC-0511-99-3R2
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 15, 2013
• Start date: September 1997
• Est. completion date: September 2000

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2000
• Est. primary completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• LMB-7 immunotoxin

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,