Lung Cancer Clinical Trial
Official title:
Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Advanced Non-Small Cell Lung Cancer (NSCLC)
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 trial to study the effectiveness of radiolabeled monoclonal antibody
therapy in treating patients who have relapsed or refractory non-small cell lung cancer.
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of yttrium Y
90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory non-small cell
lung cancer. II. Determine the dosimetric and pharmacokinetic properties of this treatment
regimen in the blood, normal organs, and tumors of these patients. III. Determine the
stability and complexation with circulating carcinoembryonic antigen of this radioantibody
in the plasma of these patients. IV. Determine the antibody response of these patients with
this treatment regimen. V. Determine the antitumor effects of this treatment regimen in
these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14
(90Y-hMN-14). Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal
antibody MN-14 IV over 30-40 minutes on day -7 or -6, followed by external scintigraphy on
days -7 or -6 to 0. Patients who show positive localization of at least one documented tumor
site receive 90Y-hMN-14 IV over 30-40 minutes on day 0. Cohorts of 3-6 patients receive
escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting
toxicity. Patients are followed at 2, 4, 8, and 12 weeks; every 3 months for 2 years; and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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