Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00006458|
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 2, 2004
Last Update Posted : March 3, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: indium In 111 monoclonal antibody MN-14 Radiation: yttrium Y 90 monoclonal antibody MN-14||Phase 1|
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.
|Study Type :||Interventional (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)|
|Study Start Date :||August 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006458
|United States, New Jersey|
|Garden State Cancer Center|
|Belleville, New Jersey, United States, 07103|
|Study Chair:||Jack D. Burton, MD||Garden State Cancer Center at the Center for Molecular Medicine and Immunology|