Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00003741|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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 with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: monoclonal antibody HeFi-1||Phase 1|
- Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
- Determine the pharmacokinetics of this drug in this patient population.
- Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study|
|Study Start Date :||February 1999|
|Actual Study Completion Date :||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003741
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Henry Koon, MD||Beth Israel Deaconess Medical Center|