NCT00028613

Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma

Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
RADIATION	iodine I 131 monoclonal antibody Lym-1

Timeline

• Start date: 2001-03-01
• Primary completion: 2001-10-01
• Completion: 2001-10-01
• First posted: 2003-06-30
• Last updated: 2014-01-09

Locations

1 site across 1 country: United States