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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Darell D. Bigner, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065605

NCT ID:

NCT00003020

Start Date:

September 1997

Completion Date:

September 2000

Related Keywords:

  • Brain and Central Nervous System Tumors
  • leptomeningeal metastases
  • Neoplasm Metastasis
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Meningeal Neoplasms
  • Meningeal Carcinomatosis

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107