Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00028613
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States