Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
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|ClinicalTrials.gov Identifier: NCT00007956|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-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 recurrent or refractory lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: monoclonal antibody mono-dgA-RFB4||Phase 1|
- Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients.
- Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients achieving complete remission or stable partial remission are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma|
|Study Start Date :||November 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): NCT00007956
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Edward A. Sausville, MD, PhD||National Cancer Institute (NCI)|