Spots Global Cancer Trial Database for Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT00028613

Conditions

Lymphoma

Interventions

iodine I 131 monoclonal antibody Lym-1

Study Description

Brief 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.