NCT00006009

Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 advanced or recurrent lymphoma.

Detailed description

OBJECTIVES: * Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. * Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population. * Determine the response in these patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 1 month and then monthly for 3 months. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.

Conditions

• Lymphoma
• Small Intestine Cancer

Interventions

Type	Name	Description
BIOLOGICAL	visilizumab

Timeline

• Start date: 2001-04-01
• Completion: 2003-10-01
• First posted: 2003-10-08
• Last updated: 2013-05-15

Locations

1 site across 1 country: United States