Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00028613|
Recruitment Status : Completed
First Posted : June 30, 2003
Last Update Posted : January 9, 2014
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: iodine I 131 monoclonal antibody Lym-1||Phase 1|
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
- Determine the safety of this drug in these patients.
- Determine the response of patients to this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 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 weekly for 8 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
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): NCT00028613
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Omer N. Koc, MD||Case Comprehensive Cancer Center|