Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006347|
Recruitment Status : Unknown
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
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 monoclonal antibody therapy in treating patients who have relapsed or refractory 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|
- 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 small cell lung cancer.
- Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients.
- Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients.
- Determine the antibody response of these patients treated with this regimen.
- 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 are stratified according to prior radiotherapy (yes vs no).
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 at least 2 of 3 or 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 within 10-14 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)|
|Study Start Date :||August 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006347
|United States, New Jersey|
|Garden State Cancer Center|
|Belleville, New Jersey, United States, 07109|
|Study Chair:||Jack D. Burton, MD||Garden State Cancer Center at the Center for Molecular Medicine and Immunology|